(247 days)
No
The summary describes mechanical and surface testing of dental implants and does not mention any AI or ML components.
Yes.
The device is intended to restore chewing function, which is a therapeutic purpose.
No
This device is a dental implant system intended to be surgically placed in the jaw bone to support prostheses for restoring chewing function. It is a therapeutic device, not a diagnostic one.
No
The device description explicitly states it includes physical components like implant systems, abutments, and abutment screws, which are hardware. The performance studies also detail mechanical testing and surface analysis of these physical implants.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the devices are "surgically placed in the bone of the upper or lower jaw to provide support for removable or fixed prothesis to restore chewing function." This describes a surgical implant for mechanical support, not a test performed on samples taken from the body to diagnose a condition.
- Device Description: The description details different types of dental implants and their components, all designed for surgical implantation.
- Performance Studies: The performance studies focus on mechanical strength, surface properties, sterilization, shelf life, and cytotoxicity – all relevant to a surgically implanted device, but not to an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
Therefore, the Tatum Surgical Dental Implant Systems are medical devices intended for surgical implantation, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Tatum Surgical Integrity Tapered, "T" and "S" Dental Implant Systems are intended to be surgically placed in the bone of the upper or lower jaw to provide support for removable or fixed prothesis to restore chewing function. It may be used with single-stage or two- stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.
The Tatum Surgical Dental "P" Plateau Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for removable or fixed prosthesis to restore chewing function. It may be used for single or multiple unit restorations and is indicated for delayed loading, placed with conventional two-stage surgical process with secondary and transmucosal healing.
The Tatum Surgical One-Piece Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for removable or fixed prosthesis to restore chewing function. It may be used for single or multiple unt restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. The 3.0 mm diameter Tatum Surgical One-Piece Implant must be splinted if two or more are used adjacent to each other.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
The subject device includes three (3) two-piece implant systems that have connections and prosthetic components in multiple designs unique to each system, including straight and angled abutments intended for single-unit and multiple-unit restorations. The subject device also includes one (1) one-piece implant system, in which the abutment portion is integral with the implant portion.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone of the upper or lower jaw
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical performance testing of the subject device was performed in conformance to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants. This testing was performed to ensure that the strength of the subject device implants, in conjunction with the subject device abutments and abutment screws, is appropriate for the intended use. The worst-case implant and abutment configuration was determined for each implant system and was tested. The fatigue limit data demonstrated that constructs of the subject device implants and abutments have sufficient strength for their intended use.
Surface area analysis was performed for the subject device implants with implant body lengths less than 7 mm and compared to a Bicon implant (cleared in K092035). Surface area analysis was performed for the subject device "P" Plateau Implant 4.5 x 6 mm implant compared to the Bicon o 4.0 x 5.0 mm implant (K092035; Bicon PN 340-255). Analyses of total surface area, surface area after 3 mm of bone loss, and bone-to-implant contact at placement were made using three-dimensional CAD models of the respective implants. For all conditions investigated, the surface area of the subject devices is greater than that of the Bicon predicate implant.
Modified surface testing was conducted on the subject device dental implants per FDA Guidance Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, issued May 12, 2002. The subject device dental implants have a surface that is grit blasted using aluminum oxide and then passivated. The information regarding the modified surface is provided in this submission, including the composition of the blast media and evidence for the removal of particles from the surface.
This sterilization cycle has been validated by the overkill method to a sterility assurance level (SAL) of 10-6 according to ISO 17665-1 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices, and ISO/TR 17665-2 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ANSI/AAMI/ISO 17665-1. BET testing is conducted on every batch of final packaged, sterile product using the Limulus amebocyte lysate (LAL) test method according to ANSI/AAMI ST72 Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing and USP Chapter regarding Bacterial Endotoxins Test.
The validated shelf life for the subject device components provided sterile is two (2) years. The shelf life was determined according to EN ISO 11607-1 Packaging for terminally packaged medical devices to be sterilized – Part 1: Requirements for materials, sterile barrier systems and packaging systems and ASTM F 1980 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. Package integrity of the sterile barrier was evaluated according to ASTM F2096 Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test) 2004, and ASTM 1140-07 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages.
Cytotoxicity testing was performed according to ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity, and ISO 10993-12 Biological evaluation of medical devices – Part 12: Sample preparation and reference materials.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K133510, K102034, K180282, K061410, K122231, K171728, K052997, K063523, K071235, K093595, K110548
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".
7/15/22
Suncoast Dental, Inc. dba Tatum Surgical % Melissa Burbage RA Sr Specialist PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
Re: K213576
Trade/Device Name: Tatum Surgical Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: November 9, 2021 Received: November 10, 2021
Dear Melissa Burbage:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Andrew Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K213576
Device Name Tatum Surgical Dental Implant System
Indications for Use (Describe)
The Tatum Surgical Integrity Tapered, "T" and "S" Dental Implant Systems are intended to be surgically placed in the bone of the upper or lower jaw to provide support for removable or fixed prothesis to restore chewing function. It may be used with single-stage or two- stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.
The Tatum Surgical Dental "P" Plateau Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for removable or fixed prosthesis to restore chewing function. It may be used for single or multiple unit restorations and is indicated for delayed loading, placed with conventional two-stage surgical process with secondary and transmucosal healing.
The Tatum Surgical One-Piece Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for removable or fixed prosthesis to restore chewing function. It may be used for single or multiple unt restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. The 3.0 mm diameter Tatum Surgical One-Piece Implant must be splinted if two or more are used adjacent to each other.
| Type of Use (Select one or both, as applicable) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
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510(k) Summary Tatum Surgical Dental Implant System
Tatum Surgical
July 15, 2022
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Suncoast Dental, Inc. dba Tatum Surgical
4500 140th Avenue North Suite 112
Clearwater, FL 33762 | | |
|---------------------------|-------------------------------------------------------------------------------------------------------|----------------------------------------|--|
| | Telephone: | +1 727-536-4880 | |
| | Fax: | +1 727-531-6005 | |
| Official Contact | Tony Fiorello, President; Freddie Dusold, Compliance Officer | | |
| Representative/Consultant | Melissa Burbage | | |
| | Kevin A. Thomas, PhD; Floyd G. Larson, MS, MBA | | |
| | PaxMed International, LLC | | |
| | 12264 El Camino Real, Suite 400 | | |
| | San Diego, CA 92130 | | |
| | Telephone: | +1 858-792-1235 | |
| | Fax: | +1 858-792-1236 | |
| | Email: | mburbage@paxmed.com | |
| | | kthomas@paxmed.com; flarson@paxmed.com | |
DEVICE NAME AND CLASSIFICATION
| Trade/Device Name | Tatum Surgical Dental Implant System |
|---|---|
| Common Name | Dental implant |
| Regulation Number | 21 CFR 872.3640 |
| Regulation Name | Endosseous dental implant |
| Regulatory Class | Class II |
| Primary Product Code | DZE |
| Secondary Product Code | NHA |
| Classification Panel | Dental Products Panel |
| Reviewing Branch | Dental Devices Branch |
PREDICATE DEVICE INFORMATION
Primary Predicate Device K133510, Neodent Implant System, JJGC Indústria e Comércio de Materiais Dentários SA.
Additional Predicate Devices K102034, Blue Sky Bio Dental Implant System, Blue Sky Bio, LLC K180282, MIS Internal Hex Dental Implant System, MIS Implants Technologies Ltd
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K122231, Xpeed AnyRidge Internal Implant System, MegaGen Implant K061410, Zimmer Dental (Advent) Implant System, Zimmer Dental, Inc. K122231, Xpeed AnyRidge Internal Implant System, MegaGen Implant K111581, NobelActive 3.0 Angled Abutment, Nobel Biocare USA, LLC K092035, Bicon Implants with 2.5 mm Internal Connection, Bicon LLC K171728, MOR Implant, Sterngold K071235, K063523, K052997, Zimmer One-Piece Implant, Zimmer Dental K093595, CeraRoot Implant System, Oral Iceberg S.L. K110548, Juell OSI O-ball Abutment Dental Implant, Juell Dental
INDICATIONS FOR USE STATEMENT
The Tatum Surgical Integrity Tapered, "T" and "S" Dental Implant Systems are intended to be surgically placed in the bone of the upper or lower jaw to provide support for removable or fixed prosthesis to restore chewing function. It may be used with single-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.
The Tatum Surgical Dental "P" Plateau Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for removable or fixed prosthesis to restore chewing function. It may be for single or multiple unit restorations and is indicated for delayed loading, placed with conventional two-stage surgical process with secondary and transmucosal healing.
The Tatum Surgical One-Piece Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for removable or fixed prosthesis to restore chewing function. It may be used for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. The 3.0 mm diameter Tatum Surgical One-Piece Implant must be splinted if two or more are used adjacent to each other.
SUBJECT DEVICE DESCRIPTION
The subject device includes three (3) two-piece implant systems that have connections and prosthetic components in multiple designs unique to each system, including straight and angled abutments intended for single-unit and multiple-unit restorations. The subject device also includes one (1) one-piece implant system, in which the abutment portion is integral with the implant portion.
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| Unipost System | |||||
|---|---|---|---|---|---|
| Implant | |||||
| Line | Integrity Tapered | ||||
| Implant System | "T" | ||||
| Tapered | |||||
| Implants | "S" | ||||
| Straight | |||||
| Implants | "P" | ||||
| Plateau | |||||
| Implant System | One-Piece | ||||
| Implant System | |||||
| Image | |||||
| Not to Scale | Image: Integrity Tapered Implant System | Image: T Tapered Implants | Image: S Straight Implants | Image: P Plateau Implant System | Image: One-Piece Implant System |
| Description | Tissue or Bone Level, | ||||
| threaded, tapered body, | |||||
| root-form implant. | Tissue Level, threaded root-form implant. | ||||
| Tapered body | Straight body | Bone Level, | |||
| finned, tapered | |||||
| body, root-form | |||||
| implant. | One-piece | ||||
| implant/abutment, | |||||
| tapered body, threaded | |||||
| root-form implant. | |||||
| Diameters | 3.7 – 8.0 mm | 3.5 - 8.0 mm | 4.5, 5.0 mm | 3.0 – 6.0 mm | |
| Lengths | 9 – 20 mm | ||||
| (no 20 mm length for 7 and 8 | |||||
| mm Ø) | 11 – 20 mm | ||||
| (no 20 mm length for 7 and 8 mm Ø) | 6 – 11 mm | 11 – 17 mm | |||
| Abutments | • Integrity Cover Screw | ||||
| • Integrity Healing Cap | |||||
| • Integrity Healing Cuff | |||||
| • Integrity Platform | |||||
| Switch Healing Cuff | |||||
| • Integrity Post 0°, 15° | |||||
| • Integrity Platform | |||||
| Switch 0°, 15°, 30 | |||||
| • Integrity One-Piece | |||||
| • Integrity Temporary | |||||
| Abutments | |||||
| • Integrity Ball Abutment | • Unipost Healing Screw | ||||
| • Unipost Healing Cuff | |||||
| • Unipost Abutments 5 mm | |||||
| height 0°, 10°, 20°, 30° | |||||
| • Unipost Abutment 9 mm | |||||
| height 0°, 10°, 20°, 30° | |||||
| • Unipost Temporary | |||||
| Abutment | |||||
| • Unipost “O” Ball Abutment | • Healing | ||||
| Abutment | |||||
| • Non-shouldered | |||||
| Abutment 0°, | |||||
| 15° | |||||
| • Shouldered | |||||
| Abutment | |||||
| • "O" Ball | |||||
| Abutment | • Straight Abutment | ||||
| • Angled Abutment | |||||
| 15° | |||||
| • Ball Abutment | |||||
| Screws | • 2.0 RH Integrity 3.7-5.0 | ||||
| • 2.5 RH Integrity 6.0-8.0 | • Healing Cuff Screw Uni | ||||
| • Unipost Abutment Screw | none | n/a |
EQUIVALENCE TO MARKETED DEVICES
Two-Piece Implants – Standard
Indications for the standard two-piece implant systems are compared to those of the primary predicate K133510, and to the additional predicates K102034, K180282, K061410, and K122231. The IFUS for the subject device is substantially equivalent to that of the primary predicate K133510 and the additional predicate devices. Slight differences in the language of the IFUS do not affect the intended use as an endosseous dental implant and dental implant abutments for support of a prosthesis to restore chewing function.
The two-piece implant subject device offers two implant placement types: bone level and tissue level. The bone level placement subject device implants are similar to the primary predicate K133510, additional
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510(k) Summary Page 4 of 13
predicates K102034, K180282, K122231, and K092035. The tissue level placement subject device implants are similar to the additional predicate K061410.
The two-piece implant subject device has an internal connection just as the other two-piece implants including the primary predicate K133510, and additional predicates K102034, K180282, and K061410, and K122231; the only difference is the type of internal connection. The two-piece implant subject device has implant diameters ranging from 3.5 mm to 8.0 mm (3.5, 3.0, 6.0, 7.0, and 8.0 mm). The smallest diameter is similar to many of the predicates. The largest diameter is similar to the additional predicate K102034 which also has an 8 mm diameter, and similar to the additional predicate K122231 which has an 8.4 mm diameter. The two-piece subject device implant lengths ranging from 9 mm to 20 mm (9, 11, 14, 17, and 20 mm); the two larger diameter implants (7 mm and 8 mm) are not offered in 20 mm length. The endosseous length of the subject device tissue level Integrity Tapered Implant is 1.5 mm less than the bone level length, resulting in lengths ranging from 7.5 mm to 18.5 mm (9. 11. 14. 17. and 20 mm). The smallest subject device endosseous length of 7.5 mm is similar to the primary predicate K133510, the additional predicate K102034, the additional predicate K180282, the additional predicate K061410 (implants with 8 mm length), and the additional predicate K122231 (implants with 7.7 mm length). The shortest subject device endosseous length is most similar to the additional predicate K122231 (implants with 7.7 mm length). The two-piece subject device "S" Implant System has a hole in the apical tip of the implant similar to additional predicate K061410.
The two-piece implant subject device has the same material, titanium alloy (Ti-6Al-4V) as the additional predicate K102034, additional predicate K092035, additional predicate K061410, and additional predicate K122231. The two-piece implant subject device has a blasted surface treatment same as the additional predicate device K102034. The two-piece subject device implants are provided sterile for single patient, single use, which is same as the primary predicate and additional predicate devices.
Two-Piece Implant Systems - "P" Plateau Implant System (Press-fit)
Indications for the "P" Plateau Implant System (press-fit) two-piece implant systems are compared to the primary predicate K133510 and to additional predicates K102034. K180282. and K092035. The IFUS for the subject device is substantially equivalent to that of the primary predicate K133510, except that the subject device is limited to delayed loading (two-stage procedure). Slight differences in the language of the IFUS do not affect the intended use as an endosseous dental implant and dental implant abutments for support of a prosthesis to restore chewing function.
The longest length of the subject device implants is similar to the additional predicate K180282. The twopiece subject device implant line that includes a "short" implant less than 7 mm length) is the "P" Plateau Implant System, with lengths ranging from 6 mm to 11 mm (6, 8, and 11 mm). The shortest implant length is similar to the additional predicate K102034, the additional predicate K180282, and the additional predicate K092035.
The "P" Plateau Implant System (press-fit) two-piece implant subject device has the same material, titanium alloy (Ti-6A1-4V) as the additional predicate K102034, additional predicate K092035, additional predicate K061410, and additional predicate K122231. The two-piece implant subject device has a blasted surface treatment same as the additional predicate device K102034. The two-piece subject device implants are provided sterile for single patient, single use, which is same as the primary predicate and additional predicate devices.
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Abutments
The subject device healing component offers diameters that correspond to the subject device implants, which range from 2.5 mm to 8.0 mm with a threaded or Morse connection. The range of diameters is similar the predicate devices. The subject device abutments are provided in diameters that correspond to the subject device implants, which range from 3.0 mm with a pentagon, threaded, or Morse taper connection, and angulation of 0°, 10°, 15°, 20°, and 30°. The diameters, connections, and angulations are similar the predicate device abutments. The subject device ball abutments are provided in diameters that correspond to the subject device implants, which range from 4.0 mm to 5.25 mm with a threaded or Morse taper connection. The subject device diameters are similar to those of the predicate device ball abutments. The subject device titanium housing and retention inserts with various retention levels are provided, similar to additional predicate device K180282 (OT-Equators & Ball Abutment system). All subject device abutments (healing components, and ball abutments) are made from titanium alloy (ASTM F136) which is same as the primary predicate and additional predicate devices.
One-Piece Implants
Indications for the subject device one-piece implants are compared to that of the additional predicates K171728, K052997, K063523, K071235, K093595, and K110548. The IFUS for the subject device is substantially equivalent to that of the additional predicate devices. Slight differences in the language of the IFUS do not affect the intended use as an endosseous dental implant and dental implant abutments for support of a prosthesis to restore chewing function.
The subject device one-piece implants have diameters ranging from 3.0 mm to 6.0 mm (3.0, 3.5. 4.0, 4.5. 5.0, and 6.0). The smallest subject device diameter is similar to that of the additional predicate devices; K171728, K052997, K063523, K071235, K093595, and K110548. The largest subject device is similar to that of the additional predicate K093595. The subject device one-piece implants do not have diameters smaller or larger than any of the predicate devices. The subject device one-piece implants have lengths ranging from 11 mm to 17 mm (11, 14, and 17). The smallest subject device length is not less than that of many of the predicate devices. The longest subject device length is no longer than any of the predicates. The one-piece implant subject device is made from the same material, titanium alloy (Ti-6Al-4V) as is the additional predicate K052997, K063523, K071235 and additional predicate K110548. The subject device one-piece implants have a blasted surface treatment has a blasted surface treatment same as the additional predicate device K102034. The subject device one-piece implants have three abutment connections, straight, 15° angled, and ball. The abutment connections are similar to those of the additional predicate K171728 (straight and ball abutments), the additional predicate K052997, K063523, K071235 (straight and 17° angled abutments), the additional predicate K093595 (straight abutments), and the additional predicate K110548 (ball abutments). The one-piece implant subject device is provided sterile, for single patient, single use, which is same as the primary predicate and additional predicate devices.
PERFORMANCE DATA
Mechanical performance testing of the subject device was performed in conformance to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants. This testing was performed to ensure that the strength of the subject device implants, in conjunction with the subject device abutments and abutment screws, is appropriate for the intended use. The worst-case implant and abutment configuration was determined for each implant system and was tested. The fatigue limit data
8
demonstrated that constructs of the subject device implants and abutments have sufficient strength for their intended use.
Surface area analysis was performed for the subject device implants with implant body lengths less than 7 mm and compared to a Bicon implant (cleared in K092035). Surface area analysis was performed for the subject device "P" Plateau Implant 4.5 x 6 mm implant compared to the Bicon Ø 4.0 x 5.0 mm implant (K092035; Bicon PN 340-255). Analyses of total surface area, surface area after 3 mm of bone loss, and bone-to-implant contact at placement were made using three-dimensional CAD models of the respective implants. For all conditions investigated, the surface area of the subject devices is greater than that of the Bicon predicate implant.
Modified surface testing was conducted on the subject device dental implants per FDA Guidance Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, issued May 12, 2002. The subject device dental implants have a surface that is grit blasted using aluminum oxide and then passivated. The information regarding the modified surface is provided in this submission, including the composition of the blast media and evidence for the removal of particles from the surface.
This sterilization cycle has been validated by the overkill method to a sterility assurance level (SAL) of 106 according to ISO 17665-1 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices, and ISO/TR 17665-2 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ANSI/AAMI/ISO 17665-1. BET testing is conducted on every batch of final packaged, sterile product using the Limulus amebocyte lysate (LAL) test method according to ANSI/AAMI ST72 Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing and USP Chapter regarding Bacterial Endotoxins Test.
The validated shelf life for the subject device components provided sterile is two (2) years. The shelf life was determined according to EN ISO 11607-1 Packaging for terminally packaged medical devices to be sterilized – Part 1: Requirements for materials, sterile barrier systems and packaging systems and ASTM F 1980 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. Package integrity of the sterile barrier was evaluated according to ASTM F2096 Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test) 2004, and ASTM 1140-07 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages.
Cytotoxicity testing was performed according to ISO 10993-5 Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity, and ISO 10993-12 Biological evaluation of medical devices – Part 12: Sample preparation and reference materials.
CONCLUSION
The subject devices, the primary predicate device and reference devices have the same intended use and similar technological characteristics. They encompass a similar range of physical dimensions and are manufactured from the same materials. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.
9
| Indications for Use Statement | |
|---|---|
| Subject Device | |
| Tatum Surgical Dental | |
| Implant System | |
| Tatum Surgical | The Tatum Surgical Integrity Tapered, "T" and "S" Dental Implant Systems are intended to be |
| surgically placed in the bone of the upper or lower jaw to provide support for removable or fixed | |
| prosthesis to restore chewing function. It may be used with single-stage or two-stage procedures, for | |
| single or multiple unit restorations, and may be loaded immediately when good primary stability is | |
| achieved and with appropriate occlusal loading. | |
| The Tatum Surgical Dental "P" Plateau Implant System is intended to be surgically placed in the bone | |
| of the upper or lower jaw to provide support for removable or fixed prosthesis to restore chewing | |
| function. It may be for single or multiple unit restorations and is indicated for delayed loading, placed | |
| with conventional two-stage surgical process with secondary and transmucosal healing. | |
| The Tatum Surgical One-Piece Dental Implant System is intended to be surgically placed in the bone | |
| of the upper or lower jaw to provide support for removable or fixed prosthesis to restore chewing | |
| function. It may be used for single or multiple unit restorations, and may be loaded immediately when | |
| good primary stability is achieved and with appropriate occlusal loading. The 3.0 mm diameter Tatum | |
| Surgical One-Piece Implant must be splinted if two or more are used adjacent to each other. | |
| Primary Predicate Device | |
| K133510 | |
| Neodent Implant System | |
| JJGC Indústria e | |
| Comércio de Materiais | |
| Dentários SA. | The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw |
| to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be | |
| used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be | |
| loaded immediately when good primary stability is achieved and with appropriate occlusal loading. | |
| Multiple tooth applications may be rigidly splinted. | |
| Additional Predicate Devices | |
| K102034 | |
| Blue Sky Bio Dental | |
| Implant System | |
| Blue Sky Bio, LLC | Intended Use for Two-Piece Implant Systems |
| *For implantation into any area of the fully edentulous maxilla and mandible for the support of a | |
| removable or fixed dental prosthesis | |
| *For single tooth or multiple unit prosthesis | |
| *For single stage or two stage surgical procedure | |
| *For immediate placement and immediate function when multiple units are splinted and for single | |
| units when adequate initial stability is achieved in type I or type II bone and under appropriate occlusal | |
| loading. Multiple units may be splinted with a bar. In edentulous cases restored with a fixed prosthesis, | |
| four or more implants must be used. | |
| *Unsplinted narrow implants and angled abutments are not to be used in the posterior areas. | |
| *Taper Hex Implant System is compatible with Nobel Active implants and prosthetics | |
| *Double Hex Implant System is compatible with Astra double hex implants and prosthetics | |
| *Square Taper Implant System is compatible with Straumann Bone-Level implants and prosthetics | |
| K180282 | |
| MIS Internal Hex Dental | |
| Implant System | |
| MIS Implants | |
| Technologies Ltd. | MIS dental implant systems are intended to be surgically placed in the bone of the upper or lower jaw |
| arches to provide support for prosthetic devices, such as artificial teeth, in order to restore masticatory | |
| function. When a one-stage surgical procedure is applied, the implant may be immediately loaded | |
| when good primary stability is achieved and the occlusal load is appropriate. | |
| Narrow implants (Ø3.3mm & UNO) are indicated for use in surgical and restorative applications for | |
| placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of | |
| partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth. Mandibular | |
| central and lateral incisors must be splinted if using two or more narrow implants adjacent to one | |
| another. | |
| The long MIS (18 & 20 mm) implants can be used in a tilted manner. | |
| MIS short implants are to be used only with straight abutments. | |
| M4 short implants are indicated for delayed loading only. | |
| K061410 | |
| Zimmer Dental (Advent) | |
| Implant System | |
| Zimmer Dental, Inc. | The Tapered Screw-Vent, Screw-Vent, AdVent, and Zimmer One-Piece 3.7 mm Dental Implants are |
| designed for use in the maxilla or mandible for immediate loading or for loading after a conventional | |
| healing period. Implants may be used to replace one or more missing teeth. Immediate loading is | |
| indicated when there is good primary stability and an appropriate occlusal load. | |
| K122231 | |
| Xpeed AnyRidge | |
| Internal Implant System | |
| MegaGen Implant | The Xpeed AnyRidge Internal Implant System is intended to be surgically placed in the maxillary or |
| mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, | |
| bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's | |
| chewing function. Smaller implants (less than 6.0 mm) are dedicated for immediate loading when good | |
| primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for | |
| the molar region and are indicated for delayed loading. | |
| K111581 | |
| NobelActive 3.0 Angled | |
| Abutment | |
| Nobel Biocare USA, | |
| LLC | The NobelActive 3.0mm implant is indicated for use in the treatment of missing maxillary lateral |
| incisors or the mandibular central and lateral incisors to support prosthetic devices, such as artificial | |
| teeth, in order to restore chewing function in partially edentulous patients. The NobelActive 3.0 | |
| implants may be put into immediate function provided that stability requirements detailed in the | |
| manual are satisfied. | |
| K092035 | |
| Bicon Implants with 2.5 | |
| mm Internal Connection | |
| Bicon LLC | The Bicon implant is designed for use in edentulous sites in the mandible or maxilla for support of a |
| complete denture prosthesis, a final or intermediate abutment for fixed bridgework or for partial | |
| dentures, or as a single tooth replacement. | |
| K171728 | |
| MOR 3.0mm and PUR | |
| NP 3.2mm Implant | |
| Systems, MOR 2.1 x | |
| 18mm and 2.4x18mm | |
| Sterngold Dental, LLC | The MORTM implants are intended to be used for oral rehabilitation of edentulous and partially dentate |
| patients in the maxilla and mandible to support single unit, and multiple unit restorations. Implant | |
| retained restorations may consist of single crowns or bridges as well as complete or partial dentures. | |
| These implants are intended for delayed loading. Immediate loading is indicated when there is good | |
| primary stability and an appropriate occlusal load. | |
| The MORTM implants are only intended for use with straight abutments. The implant body is intended | |
| to be placed such no angle correction is necessary. | |
| K071235 (3.0 angled) | |
| K063523 (3.7 and 4.7 | |
| straight and angled) | |
| K052997 (3.0 and 3.7 | |
| straight) | |
| Zimmer One-Piece | |
| Zimmer Dental, Inc. | Zimmer One-Piece 3.0mmD Implants are indicated for the support and retention of fixed single-tooth |
| and fixed partial denture restorations in the mandibular central and lateral incisor and maxillary lateral | |
| incisor regions of partially edentulous jaws. The 3.0mmD Zimmer One-Piece Implant must be splinted | |
| if two or more are used adjacent to each other, and may be immediately restored with a temporary | |
| prosthesis that is not in functional occlusion. | |
| Zimmer One-Piece 3.7mmD and 4.7mmD Implants are designed for use in the maxilla or mandible for | |
| immediate loading, or for loading after a conventional healing period. Implants may be used to replace | |
| one or more missing teeth. Immediate loading is indicated when there is good primary stability and an | |
| appropriate occlusal load. | |
| K093595 | |
| CeraRoot Implant | |
| System | |
| Oral Iceberg S.L. | CeraRoot dental implants are especially designed for the surgical implantation in the maxilla and |
| mandible for the retention of fixed prosthetic devices, such as an artificial tooth, in order to restore | |
| patient aesthetics and chewing function. The CeraRoot dental implants can be used for single or | |
| multiple unit restorations in splinted or non-splinted applications. CeraRoot implants can be placed in | |
| immediate or delayed tooth extractions. CeraRoot implants are not intended for immediate loading. | |
| The CeraRoot dental implants are specially indicated in patients with metal allergies and chronic | |
| illness due to metal allergies. | |
| K110548 | |
| Juell OSI O-ball | |
| Abutment Dental | |
| Implant | |
| Juell Dental | The OSI O-ball Abutment implant is a self-tapping titanium threaded screw indicated for long term |
| intra-bony fixation of upper and lower dentures in edentulous cases. These devices will permit | |
| immediate splinting and ability and short-term fixation of failing crown and bridge installations, for | |
| full or partial edentulism. They can be used in the anterior regions of the maxillary and mandibular | |
| arches and are indicated for immediate loading when there is good primary stability and appropriate | |
| occlusal load. |
Table of Substantial Equivalence – Indications for Use Statement
10
11
| Feature | Subject Device | Primary Predicate | Additional Predicate | Additional Predicate | Additional Predicate | Additional Predicate | Additional Predicate | Additional Predicate | ||
|---|---|---|---|---|---|---|---|---|---|---|
| Tatum Surgical Dental Implant | ||||||||||
| System | ||||||||||
| Tatum Surgical | K133510 | |||||||||
| Neodent Implant System | ||||||||||
| JJGC Industria e Comercio de | ||||||||||
| Materiais Dentarios SA | K102034 | |||||||||
| Blue Sky Bio Dental Implant System | ||||||||||
| Blue Sky Bio, LLC | K180282 | |||||||||
| MIS Internal Hex Dental Implant | ||||||||||
| System | ||||||||||
| MIS Implants Technologies Ltd. | K061410 (Advent) | |||||||||
| Zimmer Dental Implant | ||||||||||
| System | ||||||||||
| Zimmer Dental | K122231 | |||||||||
| Xpeed AnyRidge Internal | ||||||||||
| Implant System | ||||||||||
| MegaGen Implant | K111581 | |||||||||
| NobelActive 3.0 Angled | ||||||||||
| Abutment | ||||||||||
| Nobel Biocare USA, LLC | K092035 | |||||||||
| Bicon Implants with 2.5 mm | ||||||||||
| Internal Connection | ||||||||||
| Bicon LLC | ||||||||||
| Product Code | DZE, NHA | DZE, NHA | DZE, NHA | DZE, NHA | DZE | DZE, NHA | NHA | DZE | ||
| Reason for Predicate/ | ||||||||||
| Reference Device | n/a | Implant narrow diameter | ||||||||
| 30° angled abutments | Implant wide diameter | |||||||||
| Short implant (6 mm) | ||||||||||
| 30° Angled Abutments | Implant length (20 mm) | |||||||||
| Short implant (6 mm) | Tissue Level and hole in | |||||||||
| apical tip | Widest x longest (6x17) | |||||||||
| 10.0 abutment | 3.0 Abutment | Surface area comparison | ||||||||
| Integrity Tapered Implant | ||||||||||
| Implant Placement | Bone Level | |||||||||
| Tissue level | Bone level | Bone level | Bone level | Tissue Level | Bone Level | |||||
| Prosthetic Interface | ||||||||||
| Connection | Internal pentagon | Internal hex | Internal hex | |||||||
| w/taper | internal square | |||||||||
| w/taper | Internal hex | Internal Hex | ||||||||
| Body/Platform Diameter, | ||||||||||
| mm | 3.7, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0 | Titamax Smart - 3.3, 3.75, 4.0, | ||||||||
| 4.5. 5.0 | ||||||||||
| Titamax Smart EX - 3.75, 4.0 | Square taper - | |||||||||
| 3.3, 4.1, 4.8, 5.6, | ||||||||||
| 7,8 | Double hex - | |||||||||
| 3.25, 3.5, 4.0, | ||||||||||
| 5.0 | 3.7/4.5, 4.7/4.5, 4.7/5.7 | Normal ridge - 4.0, 4.4, 4.9, | ||||||||
| 5.4, 5.9 | ||||||||||
| low ridge - 6.4, 6.9, 7.4, 7.9, | ||||||||||
| 8.4 | ||||||||||
| Total Lengths, mm | 9, 11, 14, 17, 20 | |||||||||
| (no 20 mm length for 7 and 8 mm Ø) | Titamax Smart - 9, 11, 13, 15, 17 | |||||||||
| Titamax Smart EX - 9, 11, 13, 15, | ||||||||||
| 17, 19 | Square taper - 8, | |||||||||
| 10, 12, 14, 16 | Double hex - | |||||||||
| 9, 11, 13, 15, | ||||||||||
| 17 | 11, 13, 16, 19 | Normal ridge - 7.7, 9.2, 10.7, | ||||||||
| 12.2, 14.2, 17.2 | ||||||||||
| Low ridge - 7.9, 9.4, 10.9, | ||||||||||
| 12.4, 14.4 | ||||||||||
| Endosseous Length, mm | 7.5, 9.5, 12.5, 15.5, | |||||||||
| 18.5 | ||||||||||
| Same as total | ||||||||||
| (no 15.5 and 18.5 | ||||||||||
| mm length for 7 | ||||||||||
| and 8 mm Ø) | Same as total length | Same as total | ||||||||
| length | Same as total | |||||||||
| length | 8, 10, 13, 16 | Same as total length | ||||||||
| Implant Material | Titanium alloy (Ti6Al-4V) | CP Titanium, Gr.4 | Titanium alloy (Ti6Al-4V) | Titanium TI-6Al-4V ELI | Titanium TI-6Al-4V ELI | CP Titanium, Gr 4 and | ||||
| Titanium TI-6Al-4V ELI | ||||||||||
| Implant Endosseous Surface | Aluminum oxide blasted and | |||||||||
| passivated | Grit blasted and acid etched | Blasted with resorbable medium, or | ||||||||
| etched | Sand blasted and acid etched | MTX Blasted | Sand-blasted, Large grit, Acid- | |||||||
| etched (SLA) | ||||||||||
| Healing Components | ||||||||||
| Cover screws, Healing caps, | ||||||||||
| Healing cuffs | Coronal Ø: 3.25-8.0 mm | |||||||||
| Gingival Height: 0-5 mm | ||||||||||
| Connection: Threaded | ||||||||||
| Titanium Alloy (ASTM F136) | Healing Components | |||||||||
| Coronal Ø: Not stated in summar | ||||||||||
| Connection: Hex | ||||||||||
| Titanium Alloy (ASTM F136) | Healing Components | |||||||||
| Coronal Ø: Narrow, Reg, Wide | ||||||||||
| Connection: Hex | ||||||||||
| Titanium Alloy (ASTM F136) | Healing Components | |||||||||
| Coronal Ø: Not stated in summary | ||||||||||
| Connection: Hex | ||||||||||
| Titanium Alloy (ASTM F136) | Not stated in summary | |||||||||
| Abutments | ||||||||||
| Post Abutment, Platform | ||||||||||
| Switch, One-Piece | ||||||||||
| Abutment, Temporary | ||||||||||
| Abutment | Coronal Ø: 3.25-5.0 mm | |||||||||
| Gingival Height: 1.4-1.5 mm | ||||||||||
| Angulation: 0°, 15°, 30° | ||||||||||
| Connection: Pentagon or threaded | ||||||||||
| Titanium Alloy (ASTM F136) | Abutments | |||||||||
| Coronal Ø: 3.3-5.0 | ||||||||||
| Angulation: 0°, 17°, 30° | ||||||||||
| Connection: Internal hex | ||||||||||
| Titanium Alloy (ASTM F136) | Taper Hex Abutments | |||||||||
| Coronal Ø: Narrow, Reg, Wide | ||||||||||
| Angulation: 0°, 15°, 25°, 30° | ||||||||||
| Connection: Hex | ||||||||||
| Titanium Alloy (ASTM F136) | Abutments | |||||||||
| Coronal Ø: Not stated in summary | ||||||||||
| Angulation: 0°, 10°, 15°, 20°, 25° | ||||||||||
| Connection: Hex | ||||||||||
| Titanium Alloy ELI (ASTM F136) | Coronal Ø: 4.0-10.0 mm | |||||||||
| Length: 8.4-16.4 mm | ||||||||||
| Angulation: 0°, 15°, 25° | ||||||||||
| Connection: Internal pentagon | ||||||||||
| or threaded | ||||||||||
| Titanium Alloy (ASTM F136) | Coronal Ø: 3.0 mm | |||||||||
| Gingival Height: Not stated | ||||||||||
| Angulation: 0°, 15° | ||||||||||
| Connection: Internal Hex | ||||||||||
| Titanium Vanadium Alloy | ||||||||||
| Ball Abutment | Coronal Ø: 4.0-5.25 mm | |||||||||
| Gingival Height: 1-5 mm | ||||||||||
| Connection: Threaded | ||||||||||
| Titanium Alloy (ASTM F136) | ||||||||||
| Nylon and Silicone Inserts | Ball-type abutments | |||||||||
| Coronal Ø: 3.3-5.0 | ||||||||||
| Connection: Hex | ||||||||||
| Titanium Alloy (ASTM F136) | Overdenture Abutment | |||||||||
| Coronal Ø: Narrow, Reg, Wide | ||||||||||
| Connection: Threaded | ||||||||||
| Titanium Alloy (ASTM F136) | Ball-type abutments | |||||||||
| Coronal Ø: Not stated in summary | ||||||||||
| Connection: Internal Hex | ||||||||||
| Titanium Alloy (ASTM F136) | ||||||||||
| Nylon Inserts | Not stated in summary | |||||||||
| Subject Device | Primary Predicate | Additional Predicate | Additional Predicate | Additional Predicate | Additional Predicate | Additional Predicate | Additional Predicate | Additional Predicate | ||
| Feature | Tatum Surgical Dental Implant | |||||||||
| System | ||||||||||
| Tatum Surgical | K133510 | |||||||||
| Neodent Implant System | ||||||||||
| JJGC Industria e Comercio de | ||||||||||
| Materiais Dentarios SA | K102034 | |||||||||
| Blue Sky Bio Dental Implant System | ||||||||||
| Blue Sky Bio, LLC | K180282 | |||||||||
| MIS Internal Hex Dental Implant | ||||||||||
| System | ||||||||||
| MIS Implants Technologies Ltd. | K061410 (Advent) | |||||||||
| Zimmer Dental Implant | ||||||||||
| System | ||||||||||
| Zimmer Dental | K122231 | |||||||||
| Xpeed AnyRidge Internal | ||||||||||
| Implant System | ||||||||||
| MegaGen Implant | K111581 | |||||||||
| NobelActive 3.0 Angled | ||||||||||
| Abutment | ||||||||||
| Nobel Biocare USA, LLC | K092035 | |||||||||
| Bicon Implants with 2.5 mm | ||||||||||
| Internal Connection | ||||||||||
| Bicon LLC | ||||||||||
| Unipost T & S Implants | Image: Tatum Surgical Dental Implant | Image: Neodent Implant System | Image: Blue Sky Bio Dental Implant System | Image: MIS Internal Hex Dental Implant | Image: Zimmer Dental Implant | Image: Xpeed AnyRidge Internal Implant | Image: NobelActive 3.0 Angled Abutment | Image: Bicon Implants with 2.5 mm Internal Connection | ||
| Implant Placement | Tissue level | Bone level | Bone level | Bone level | Tissue Level | Bone Level | ||||
| Prosthetic Interface | ||||||||||
| Connection | Internal pentagon | Internal hex | Internal hex | |||||||
| w/taper | Internal hex | Internal hex | Internal Hex | |||||||
| Body/Platform Diameter, | ||||||||||
| mm | 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0 | Titamax Smart - 3.3, 3.75, 4.0, | ||||||||
| 4.5, 5.0 | ||||||||||
| Titamax Smart EX - 3.75, 4.0 | Square taper - | |||||||||
| 3.3, 4.1, 4.8, 5.6, | ||||||||||
| 7, 8 | Ø 3.3 - 10 ,11.5, 13, 16 | |||||||||
| Ø 3.75 - 8, 10, 11.5, 13, 16, 18, 20 | ||||||||||
| Ø 4.2-6, 8, 10, 11.5, 13, 16, 18, 20 | ||||||||||
| Ø 5.0-6, 8, 10, 11.5, 13, 16 | ||||||||||
| Ø 6.0 - 6, 8, 10, 11.5, 13 | 3.7/4.5, 4.7/4.5, 4.7/5.7 | Normal ridge - 4.0, 4.4, 4.9, | ||||||||
| 5.4, 5.9 | ||||||||||
| low ridge - 6.4, 6.9, 7.4, 7.9, | ||||||||||
| 8.4 | ||||||||||
| Total Lengths, mm | 11, 14, 17, 20 | |||||||||
| (no 20 mm length for 7 and 8 mm Ø) | Titamax Smart - 9, 11, 13, 15, 17 | |||||||||
| Titamax Smart EX - 9, 11, 13, 15, | ||||||||||
| 17, 19 | Square taper - 8, | |||||||||
| 10, 12, 14, 16 | 11, 13, 16, 19 | Normal ridge - 7.7, 9.2, 10.7, | ||||||||
| 12.2, 14.2, 17.2 | ||||||||||
| Low ridge - 7.9, 9.4, 10.9, | ||||||||||
| 12.4, 14.4 | ||||||||||
| Endosseous Length, mm | 7.5, 9.5, 12.5, 15.5, 18.5 | |||||||||
| (no 15.5 and 18.5 mm length for 7 and | ||||||||||
| 8 mm Ø) | Same as total length | Same as total | ||||||||
| length | Same as total length | 8, 10, 13, 16 | Same as total length | |||||||
| Apical Hole | No and Yes | No | No | No | Yes | No | ||||
| Implant Material | Titanium alloy (Ti6Al-4V) | CP Titanium, Gr.4 | Titanium alloy (Ti6Al-4V) | Titanium TI-6Al-4V ELI | Titanium TI-6Al-4V ELI | CP Titanium, Gr 4 and | ||||
| Titanium TI-6Al-4V ELI | ||||||||||
| Implant Endosseous Surface | Aluminum oxide blasted and | |||||||||
| passivated | grit blasted and acid etched | Blasted with resorbable medium, or | ||||||||
| etched | Sand blasted and acid etched | MTX Blasted | Sand-blasted, Large grit, Acid- | |||||||
| etched (SLA) | ||||||||||
| Healing Components | ||||||||||
| Healing screws, Healing | ||||||||||
| cuffs | Coronal Ø: 2.5-8.0 mm | |||||||||
| Gingival Height: 2.4-3.63 mm | ||||||||||
| Connection: Threaded | ||||||||||
| Titanium Alloy (ASTM F136) | Cover Screws and Healing | |||||||||
| Abutments | ||||||||||
| Coronal Ø: Not stated in summary | ||||||||||
| Connection: Hex | ||||||||||
| Titanium Alloy (ASTM F136) | Cover Screws and Healing | |||||||||
| Abutments | ||||||||||
| Coronal Ø: Narrow, Reg, Wide | ||||||||||
| Connection: Hex | ||||||||||
| Titanium Alloy (ASTM F136) | Cover Screws and Healing | |||||||||
| Abutments | ||||||||||
| Coronal Ø: Not stated in summary | ||||||||||
| Connection: Hex | ||||||||||
| Titanium Alloy (ASTM F136) | Not stated in summary | |||||||||
| Abutments | ||||||||||
| Unipost Abutment, | ||||||||||
| Temporary Abutment | Coronal Ø: 3.0-7.0 mm | |||||||||
| Gingival Height: 0-5 mm | ||||||||||
| Angulation: 0°, 20°, 30° | ||||||||||
| Connection: Threaded | ||||||||||
| Titanium Alloy (ASTM F136) | Abutments | |||||||||
| Coronal Ø: 3.3-5.0 | ||||||||||
| Angulation: 0°, 17°, 30° | ||||||||||
| Connection: Hex | ||||||||||
| Titanium Alloy (ASTM F136) | Taper Hex Abutments | |||||||||
| Coronal Ø: Narrow, Reg, Wide | ||||||||||
| Angulation: 0°, 15°, 25°, 30° | ||||||||||
| Connection: Hex | ||||||||||
| Titanium Alloy (ASTM F136) | Abutments | |||||||||
| Coronal Ø: Not stated in summary | ||||||||||
| Angulation: 0°, 10°, 15°, 20°, 25° | ||||||||||
| Connection: Hex | ||||||||||
| Titanium Alloy ELI (ASTM F136) | Coronal Ø: 4.0-10.0 mm | |||||||||
| Length: 8.4-16.4 mm | ||||||||||
| Angulation: 0°, 15°, 25° | ||||||||||
| Connection: Internal pentagon | ||||||||||
| or threaded | ||||||||||
| Titanium Alloy (ASTM F136) | Coronal Ø: 3.0 mm | |||||||||
| Gingival Height: Not stated | ||||||||||
| Angulation: 0°, 15° | ||||||||||
| Connection: Internal Hex | ||||||||||
| Titanium Vanadium Alloy | ||||||||||
| Ball Abutment | Coronal Ø: 3.5-4.5 mm | |||||||||
| Gingival Height: 1-5 mm | ||||||||||
| Connection: Threaded | ||||||||||
| Titanium Alloy (ASTM F136) | ||||||||||
| Nylon and Silicone Inserts | Ball-type abutments | |||||||||
| Coronal Ø: 3.3-5.0 | ||||||||||
| Connection: Hex | ||||||||||
| Titanium Alloy (ASTM F136) | Overdenture Abutment | |||||||||
| Coronal Ø: Narrow, Reg, Wide | ||||||||||
| Connection: Threaded | ||||||||||
| Titanium Alloy (ASTM F136) | Ball-type abutments | |||||||||
| Coronal Ø: Not stated in summary | ||||||||||
| Connection: Hex | ||||||||||
| Titanium Alloy (ASTM F136) | ||||||||||
| Nylon Inserts | Not stated in summary | |||||||||
| P Implants | ||||||||||
| Implant Placement | Bone level | Bone level | Bone level | Bone level | ||||||
| Prosthetic Interface | ||||||||||
| Connection | Morse taper | Internal hex w/ taper | Internal hex | Morse taper | ||||||
| Body/Platform Diameter, | ||||||||||
| mm | 4.5, 5.0 | 4.8, 5.6, 7.0, 8.0 | Ø 4.2 - 6, 8, 10, 11.5, 13, 16, 18, 20 | |||||||
| Ø 5.0-6, 8, 10, 11.5, 13, 16 | ||||||||||
| 06.0-6, 8, 10, 11.5, 13 | Ø 4.0-5, 8, 11 | |||||||||
| Ø 4.5 – 8, 11 | ||||||||||
| Total Lengths, mm | 6, 8, 11 | 6 | From marketing material, | |||||||
| not stated in 510(k) | ||||||||||
| Summary | ||||||||||
| Endosseous Length, mm | Same as total length | 7.8 | Same as total length | Same as total length | ||||||
| Implant Collar, mm | None | 1.8 | None | None |
12
13
| Subject Device | Primary Predicate | Additional Predicate | Additional Predicate | Additional Predicate | Additional Predicate | Additional Predicate | Additional Predicate | |
|---|---|---|---|---|---|---|---|---|
| Feature | Tatum Surgical Dental Implant | |||||||
| System | ||||||||
| Tatum Surgical | K133510 | |||||||
| Neodent Implant System | ||||||||
| JJGC Industria e Comercio de | ||||||||
| Materiais Dentarios SA | K102034 | |||||||
| Blue Sky Bio Dental Implant System | ||||||||
| Blue Sky Bio, LLC | K180282 | |||||||
| MIS Internal Hex Dental Implant | ||||||||
| System | ||||||||
| MIS Implants Technologies Ltd. | K061410 (Advent) | |||||||
| Zimmer Dental Implant | ||||||||
| System | ||||||||
| Zimmer Dental | K122231 | |||||||
| Xpeed AnyRidge Internal | ||||||||
| Implant System | ||||||||
| MegaGen Implant | K111581 | |||||||
| NobelActive 3.0 Angled | ||||||||
| Abutment | ||||||||
| Nobel Biocare USA, LLC | K092035 | |||||||
| Bicon Implants with 2.5 mm | ||||||||
| Internal Connection | ||||||||
| Bicon LLC | ||||||||
| Implant Material | Titanium alloy (Ti6Al-4V) | Titanium alloy (Ti6Al-4V) | Titanium TI-6Al-4V ELI | Titanium alloy (Ti6Al-4V) | ||||
| Implant Endosseous Surface | Aluminum oxide blasted and | |||||||
| passivated | Blasted with resorbable medium, or | |||||||
| etched | Sand blasted and acid etched | Grit blasted, acid etched, | ||||||
| and hydroxylapatite | ||||||||
| Healing Components | ||||||||
| Healing Abutments | Coronal Ø: 4.5-5.0 mm | |||||||
| Connection: Morse | ||||||||
| Titanium Alloy (ASTM F136) | Cover Screws and Healing | |||||||
| Abutments | ||||||||
| Coronal Ø: Narrow, Reg, Wide | ||||||||
| Connection: Hex | ||||||||
| Titanium Alloy (ASTM F136) | Coronal Ø: Not stated in summary | |||||||
| Connection: Hex | ||||||||
| Titanium Alloy (ASTM F136) | ||||||||
| Abutment | ||||||||
| Non-shouldered Abutment, | ||||||||
| Shouldered Abutment | Coronal Ø: 4.5-5.0 mm | |||||||
| Gingival Height: 2-6 mm | ||||||||
| Angulation: 0°, 15° | ||||||||
| Connection: Morse | ||||||||
| Titanium Alloy (ASTM F136) | Taper Hex Abutments | |||||||
| Coronal Ø: Narrow, Reg, Wide | ||||||||
| Angulation: 0°, 15°, 25°, 30° | ||||||||
| Connection: Hex | ||||||||
| Titanium Alloy (ASTM F136) | Coronal Ø: Not stated in summary | |||||||
| Angulation: 0°, 10°, 15°, 20°, 25° | ||||||||
| Connection: Hex | ||||||||
| Titanium Alloy ELI (ASTM F136) | ||||||||
| Ball Abutment | Coronal Ø: 4.5-5.0 mm | |||||||
| Gingival Height: 1.5-3.5 mm | ||||||||
| Connection: Morse | ||||||||
| Titanium Alloy (ASTM F136) | ||||||||
| Nylon and Silicone Inserts | Overdenture Abutment | |||||||
| Coronal Ø: Narrow, Reg, Wide | ||||||||
| Connection: Threaded | ||||||||
| Titanium Alloy (ASTM F136) | Coronal Ø: Not stated in summary | |||||||
| Connection: Hex | ||||||||
| Titanium Alloy (ASTM F136) | ||||||||
| Nylon Inserts | ||||||||
| How Provided | ||||||||
| Sterility | Sterile implants, nonsterile abutments | Sterile implants, nonsterile | ||||||
| abutments | Sterile implants, nonsterile | |||||||
| abutments | Sterile implants, nonsterile | |||||||
| abutments | Sterile implants | Sterile implants, nonsterile | ||||||
| abutments | Nonsterile abutments | Sterile implants, nonsterile | ||||||
| abutments | ||||||||
| Usage | Single patient, single-use | Single patient, single-use | Single patient, single-use | Single patient, single-use | Single patient, single-use | Single patient, single-use | Single patient, single-use | Single patient, single-use |
14
| Subject Device | Additional Predicate | Additional Predicate | Additional Predicate | Additional Predicate | |
|---|---|---|---|---|---|
| Feature | Tatum Surgical | K171728 | |||
| MOR 3.0mm and | |||||
| PUR NP 3.2mm | |||||
| Implant Systems, | |||||
| MOR 2.1 x 18mm | |||||
| and 2.4x18mm | |||||
| Sterngold Dental, | |||||
| LLC | K071235 (3.0 angled), | ||||
| K063523 (3.7 & 4.7 | |||||
| straight & angled) | |||||
| K052997 (3.0 and 3.7 | |||||
| straight) | |||||
| Zimmer One-Piece | |||||
| Zimmer Dental, Inc. | K093595 | ||||
| CeraRoot Implant | |||||
| System | |||||
| Oral Iceberg S.L. | K110548 | ||||
| OSI O-ball Abutment | |||||
| Dental Implant | |||||
| Juell Dental | |||||
| Product Code | DZE, NHA | DZE, NHA | DZE, NHA | DZE, NHA | DZE, NHA |
| Reason for | |||||
| Predicate/ | |||||
| Reference Device | n/a | Straight & Ball | |||
| Abutment | |||||
| Narrow x short | |||||
| (2.1x10) | |||||
| Narrow x long | |||||
| (2.1&18) | Straight & Angled | ||||
| Abutment | |||||
| Narrow x short | |||||
| (3.0x10) | Straight Abutment | ||||
| Wide x short (6.5x8) | |||||
| Wide x long (6.5x14) | Ball Abutment | ||||
| Wide x long (4.5x18) | |||||
| One-Piece | |||||
| Implants, | |||||
| Straight | |||||
| Abutment | Image: One-Piece Implants, Straight Abutment | Image: One-Piece Implants, Straight Abutment | Image: One-Piece Implants, Straight Abutment | Image: One-Piece Implants, Straight Abutment | Image: One-Piece Implants, Straight Abutment |
| Body/Platform | |||||
| Diameter, mm | 3.0, 3.5, 4.0, 4.5, | ||||
| 5.0, 6.0 | 2.1, 2.4, 3.0 | 3.0, 3.7, 4.7 | 3.5, 4.1, 4.8, 6.0, 6.5 | ||
| Endosseous | |||||
| Lengths, mm | 11, 14, 17 | ||||
| (no 11 for angled) | 10, 13, 15, 18 | 10, 11.5, 13, 16 | |||
| (no 16 for 3.0) | 8, 10, 12, 14 | ||||
| Abutment Collar, | |||||
| mm | 1.5 | Not stated in 510(k) | |||
| summary | 0.5 | 3.5 | |||
| Abutment Type | Straight | Straight | Straight | Straight | |
| Implant Material | Titanium alloy | ||||
| (Ti6Al-4V) | Wrought titanium | ||||
| 6AL-4V | |||||
| ELI | Titanium alloy | ||||
| (Ti6Al-4V) | Zirconia | ||||
| Implant | |||||
| Endosseous | |||||
| Surface | Aluminum Oxide | ||||
| (Al2O3) Blasted, | |||||
| passivated | Roughened - blasted | ||||
| and acid | |||||
| Etched | Grit blasted | None | |||
| Abutment | Straight | Straight | Straight | Straight | |
| One-Piece | |||||
| Implants, Angled | |||||
| Abutment | Image: One-Piece Implants, Angled Abutment | ||||
| Body/Platform | |||||
| Diameter, mm | 3.0, 3.5, 4.0, 4.5 | 3.0, 3.7, 4.7 | |||
| Endosseous | |||||
| Length, mm | 14, 17 | 10, 11.5, 13, 16 (no 16 | |||
| for 3.0) | |||||
| Abutment Collar, | |||||
| mm | 1.5 | 0.5 | |||
| Implant Material | Titanium alloy | ||||
| (Ti6Al-4V) | Titanium alloy | ||||
| (Ti6Al-4V) | |||||
| Implant | |||||
| Endosseous | |||||
| Surface | Aluminum Oxide | ||||
| (Al2O3) Blasted, | |||||
| passivated | Grit blasted | ||||
| Subject Device | Additional | ||||
| Predicate | Additional Predicate | Additional Predicate | Additional Predicate | ||
| Feature | Tatum Surgical | K171728 | |||
| MOR 3.0mm and | |||||
| PUR NP 3.2mm | |||||
| Implant Systems, | |||||
| MOR 2.1 x 18mm | |||||
| and 2.4x18mm | |||||
| Sterngold Dental, | |||||
| LLC | K071235 (3.0 angled), | ||||
| K063523 (3.7 & 4.7 | |||||
| straight & angled) | |||||
| K052997 (3.0 and 3.7 | |||||
| straight) | |||||
| Zimmer One-Piece | |||||
| Zimmer Dental, Inc. | K093595 | ||||
| CeraRoot Implant | |||||
| System | |||||
| Oral Iceberg S.L. | K110548 | ||||
| OSI O-ball Abutment | |||||
| Dental Implant | |||||
| Juell Dental | |||||
| One-Piece | |||||
| Implants with | |||||
| Ball Abutment | Image: Tatum Surgical Implant | Image: K171728 Implant | Image: K071235 Implant | Image: K110548 Implant | |
| Body/Platform | |||||
| Diameter, mm | 3.0, 3.5, 4.0, 4.5, 5.0 | 2.1, 2.4, 3.0 | 3.0, 3.5, 4.0, 4.5 | ||
| Endosseous | |||||
| Lengths, mm | 11, 14, 17 | 10, 13, 15, 18 | 10, 13, 15, 17, 18 | ||
| Abutment Collar, | |||||
| mm | 1.5 | Not stated in 510(k) | |||
| summary | Not stated in 510(k) | ||||
| summary | |||||
| Implant Material | Titanium alloy | ||||
| (Ti6Al-4V) | Wrought titanium | ||||
| 6AL-4V ELI | Titanium alloy (Ti6Al- | ||||
| 4V) F136 | |||||
| Implant | |||||
| Endosseous | |||||
| Surface | Aluminum Oxide | ||||
| (Al2O3) Blasted, | |||||
| passivated | Roughened - blasted | ||||
| and acid | |||||
| etched | Blasted and clean | ||||
| Abutment | Ball | Ball | Ball | ||
| How Provided | |||||
| Sterility | Sterile | Sterile | Sterile | Sterile | Sterile |
| Usage | Single patient, | ||||
| single-use | Single patient, single- | ||||
| use | Single patient, single- | ||||
| use | Single patient, single- | ||||
| use | Single patient, single- | ||||
| use |
Table of Substantial Equivalence – Technological Characteristics – One-Piece Implants
15