Tatum Surgical Dental Implant System by Suncoast Dental, Inc. dba 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 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.

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.

AI/ML Overview

This document describes the Tatum Surgical Dental Implant System, a Class II medical device, and its substantial equivalence to previously cleared predicate devices. It focuses on the technical specifications and performance data rather than diagnostic or AI-assisted performance for an acceptance criterion.

Therefore, the requested information regarding acceptance criteria and studies proving the device meets them, particularly concerning human reader improvement with AI assistance, standalone algorithm performance, number of experts for ground truth, sample sizes for training and test sets, and data provenance, cannot be extracted from this document.

The document details the following technical and performance aspects:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present acceptance criteria in a quantitative table format with corresponding reported device performance, as would be typical for an AI/diagnostic device. Instead, it provides:

Indications for Use (IFU) Statement Comparison: (Pages 9-10) This section compares the IFU of the subject device (Tatum Surgical Dental Implant System) against several predicate devices (e.g., Neodent Implant System, Blue Sky Bio Dental Implant System, MIS Internal Hex Dental Implant System). The acceptance criterion implicitly is "substantial equivalence" of the IFU. The reported performance is that "The IFUS for the subject device is substantially equivalent to that of the primary predicate K133510 and the additional predicate devices."
Technological Characteristics Comparison: (Pages 11-15) This extensive table compares various features of the subject device (Tatum Surgical Dental Implant System) across its different implant lines (Integrity Tapered, "T" and "S" Implants, "P" Plateau Implant System, One-Piece Implant System) with numerous predicate devices. The features compared include:
- Product Code
- Implant Placement (Bone Level, Tissue Level)
- Prosthetic Interface Connection (Internal pentagon, Internal hex, Morse taper)
- Body/Platform Diameter (mm)
- Total Lengths (mm)
- Endosseous Length (mm)
- Apical Hole (Yes/No)
- Implant Material (Titanium alloy (Ti6Al-4V), CP Titanium, Gr.4, Titanium TI-6Al-4V ELI, Zirconia)
- Implant Endosseous Surface (Aluminum oxide blasted and passivated, Grit blasted and acid etched, Blasted with resorbable medium, etched, Sand blasted and acid etched, MTX Blasted, Sand-blasted, Large grit, Acid-etched (SLA), Roughened - blasted and acid Etched, Blasted and clean, None)
- Healing Components (Coronal Ø, Gingival Height, Connection, Material)
- Abutments (Coronal Ø, Gingival Height, Angulation, Connection, Material)
- Ball Abutments (Coronal Ø, Gingival Height, Connection, Material)
- Abutment Type (Straight)
- Sterility
- Usage (Single patient, single-use)
The reported device performance for these features is stated directly in the table, demonstrating the similarities or minor differences to the predicate devices, thereby supporting the claim of substantial equivalence.

2. Sample size used for the test set and the data provenance:

This information is not provided in the document. The document describes a medical device (dental implants) and its substantial equivalence based on material properties, design, and mechanical testing, not a diagnostic algorithm or AI.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable and not provided as this document does not concern a diagnostic device requiring expert-established ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not applicable and not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable and not provided.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This information is not applicable and not provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

This information is not applicable and not provided. The ground for this device's acceptance is based on demonstrating substantial equivalence to predicate devices through technical characteristics and mechanical performance testing, not through diagnostic accuracy against a ground truth.

8. The sample size for the training set:

This information is not provided. The acceptance of this device is based on "substantial equivalence" to existing cleared devices, supported by performance testing (mechanical, surface analysis, sterilization, shelf-life, biocompatibility), rather than a machine learning training and test set paradigm.

9. How the ground truth for the training set was established:

This information is not applicable and not provided as there is no mention of a training set or ground truth in the context of an AI/diagnostic device.

Summary

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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.

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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)

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 Surgical4500 140th Avenue North Suite 112Clearwater, 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

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	Unipost System
ImplantLine	Integrity TaperedImplant System	"T"TaperedImplants	"S"StraightImplants	"P"PlateauImplant System	One-PieceImplant System
ImageNot 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, taperedbody, root-formimplant.	One-pieceimplant/abutment,tapered body, threadedroot-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 8mm 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 PlatformSwitch Healing Cuff• Integrity Post 0°, 15°• Integrity PlatformSwitch 0°, 15°, 30• Integrity One-Piece• Integrity TemporaryAbutments• Integrity Ball Abutment	• Unipost Healing Screw• Unipost Healing Cuff• Unipost Abutments 5 mmheight 0°, 10°, 20°, 30°• Unipost Abutment 9 mmheight 0°, 10°, 20°, 30°• Unipost TemporaryAbutment• Unipost “O” Ball Abutment		• HealingAbutment• Non-shoulderedAbutment 0°,15°• ShoulderedAbutment• "O" BallAbutment	• Straight Abutment• Angled Abutment15°• 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

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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 <85> 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.

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	Indications for Use Statement
Subject Device
Tatum Surgical DentalImplant SystemTatum Surgical	The Tatum Surgical Integrity Tapered, "T" and "S" Dental Implant Systems are intended to besurgically placed in the bone of the upper or lower jaw to provide support for removable or fixedprosthesis to restore chewing function. It may be used with single-stage or two-stage procedures, forsingle or multiple unit restorations, and may be loaded immediately when good primary stability isachieved and with appropriate occlusal loading.
	The Tatum Surgical Dental "P" Plateau Implant System is intended to be surgically placed in the boneof the upper or lower jaw to provide support for removable or fixed prosthesis to restore chewingfunction. It may be for single or multiple unit restorations and is indicated for delayed loading, placedwith 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 boneof the upper or lower jaw to provide support for removable or fixed prosthesis to restore chewingfunction. It may be used for single or multiple unit restorations, and may be loaded immediately whengood primary stability is achieved and with appropriate occlusal loading. The 3.0 mm diameter TatumSurgical One-Piece Implant must be splinted if two or more are used adjacent to each other.
Primary Predicate Device
K133510Neodent Implant SystemJJGC Indústria eComércio de MateriaisDentários SA.	The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jawto provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may beused with single-stage or two-stage procedures, for single or multiple unit restorations, and may beloaded immediately when good primary stability is achieved and with appropriate occlusal loading.Multiple tooth applications may be rigidly splinted.
Additional Predicate Devices
K102034Blue Sky Bio DentalImplant SystemBlue Sky Bio, LLC	Intended Use for Two-Piece Implant SystemsFor implantation into any area of the fully edentulous maxilla and mandible for the support of aremovable or fixed dental prosthesisFor single tooth or multiple unit prosthesisFor single stage or two stage surgical procedureFor immediate placement and immediate function when multiple units are splinted and for singleunits when adequate initial stability is achieved in type I or type II bone and under appropriate occlusalloading. 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 prostheticsDouble Hex Implant System is compatible with Astra double hex implants and prostheticsSquare Taper Implant System is compatible with Straumann Bone-Level implants and prosthetics
K180282MIS Internal Hex DentalImplant SystemMIS ImplantsTechnologies Ltd.	MIS dental implant systems are intended to be surgically placed in the bone of the upper or lower jawarches to provide support for prosthetic devices, such as artificial teeth, in order to restore masticatoryfunction. When a one-stage surgical procedure is applied, the implant may be immediately loadedwhen 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 forplacement only in the mandibular central, lateral incisor and maxillary lateral incisor regions ofpartially edentulous jaws, to provide support for prosthetic devices such as artificial teeth. Mandibularcentral and lateral incisors must be splinted if using two or more narrow implants adjacent to oneanother.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.

K061410Zimmer Dental (Advent)Implant SystemZimmer Dental, Inc.	The Tapered Screw-Vent, Screw-Vent, AdVent, and Zimmer One-Piece 3.7 mm Dental Implants aredesigned for use in the maxilla or mandible for immediate loading or for loading after a conventionalhealing period. Implants may be used to replace one or more missing teeth. Immediate loading isindicated when there is good primary stability and an appropriate occlusal load.
K122231Xpeed AnyRidgeInternal Implant SystemMegaGen Implant	The Xpeed AnyRidge Internal Implant System is intended to be surgically placed in the maxillary ormandibular 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'schewing function. Smaller implants (less than 6.0 mm) are dedicated for immediate loading when goodprimary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated forthe molar region and are indicated for delayed loading.
K111581NobelActive 3.0 AngledAbutmentNobel Biocare USA,LLC	The NobelActive 3.0mm implant is indicated for use in the treatment of missing maxillary lateralincisors or the mandibular central and lateral incisors to support prosthetic devices, such as artificialteeth, in order to restore chewing function in partially edentulous patients. The NobelActive 3.0implants may be put into immediate function provided that stability requirements detailed in themanual are satisfied.
K092035Bicon Implants with 2.5mm Internal ConnectionBicon LLC	The Bicon implant is designed for use in edentulous sites in the mandible or maxilla for support of acomplete denture prosthesis, a final or intermediate abutment for fixed bridgework or for partialdentures, or as a single tooth replacement.
K171728MOR 3.0mm and PURNP 3.2mm ImplantSystems, MOR 2.1 x18mm and 2.4x18mmSterngold Dental, LLC	The MORTM implants are intended to be used for oral rehabilitation of edentulous and partially dentatepatients in the maxilla and mandible to support single unit, and multiple unit restorations. Implantretained 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 goodprimary stability and an appropriate occlusal load.The MORTM implants are only intended for use with straight abutments. The implant body is intendedto be placed such no angle correction is necessary.
K071235 (3.0 angled)K063523 (3.7 and 4.7straight and angled)K052997 (3.0 and 3.7straight)Zimmer One-PieceZimmer Dental, Inc.	Zimmer One-Piece 3.0mmD Implants are indicated for the support and retention of fixed single-toothand fixed partial denture restorations in the mandibular central and lateral incisor and maxillary lateralincisor regions of partially edentulous jaws. The 3.0mmD Zimmer One-Piece Implant must be splintedif two or more are used adjacent to each other, and may be immediately restored with a temporaryprosthesis that is not in functional occlusion.Zimmer One-Piece 3.7mmD and 4.7mmD Implants are designed for use in the maxilla or mandible forimmediate loading, or for loading after a conventional healing period. Implants may be used to replaceone or more missing teeth. Immediate loading is indicated when there is good primary stability and anappropriate occlusal load.
K093595CeraRoot ImplantSystemOral Iceberg S.L.	CeraRoot dental implants are especially designed for the surgical implantation in the maxilla andmandible for the retention of fixed prosthetic devices, such as an artificial tooth, in order to restorepatient aesthetics and chewing function. The CeraRoot dental implants can be used for single ormultiple unit restorations in splinted or non-splinted applications. CeraRoot implants can be placed inimmediate 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 chronicillness due to metal allergies.
K110548Juell OSI O-ballAbutment DentalImplantJuell Dental	The OSI O-ball Abutment implant is a self-tapping titanium threaded screw indicated for long termintra-bony fixation of upper and lower dentures in edentulous cases. These devices will permitimmediate splinting and ability and short-term fixation of failing crown and bridge installations, forfull or partial edentulism. They can be used in the anterior regions of the maxillary and mandibulararches and are indicated for immediate loading when there is good primary stability and appropriateocclusal load.

Table of Substantial Equivalence – Indications for Use Statement

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{11}------------------------------------------------

	Feature	Subject Device	Primary Predicate	Additional Predicate		Additional Predicate	Additional Predicate	Additional Predicate	Additional Predicate	Additional Predicate
		Tatum Surgical Dental ImplantSystemTatum Surgical	K133510Neodent Implant SystemJJGC Industria e Comercio deMateriais Dentarios SA	K102034Blue Sky Bio Dental Implant SystemBlue Sky Bio, LLC		K180282MIS Internal Hex Dental ImplantSystemMIS Implants Technologies Ltd.	K061410 (Advent)Zimmer Dental ImplantSystemZimmer Dental	K122231Xpeed AnyRidge InternalImplant SystemMegaGen Implant	K111581NobelActive 3.0 AngledAbutmentNobel Biocare USA, LLC	K092035Bicon Implants with 2.5 mmInternal ConnectionBicon 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 diameter30° angled abutments	Implant wide diameterShort implant (6 mm)30° Angled Abutments		Implant length (20 mm)Short implant (6 mm)	Tissue Level and hole inapical tip	Widest x longest (6x17)10.0 abutment	3.0 Abutment	Surface area comparison
	Integrity Tapered Implant
	Implant Placement	Bone LevelTissue level	Bone level	Bone level		Bone level	Tissue Level	Bone Level
	Prosthetic InterfaceConnection	Internal pentagon	Internal hex	Internal hexw/taper		internal squarew/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. 5.0Titamax 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, 5.9low 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, 17Titamax 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, 17.2Low ridge - 7.9, 9.4, 10.9,12.4, 14.4
	Endosseous Length, mm	7.5, 9.5, 12.5, 15.5,18.5Same as total(no 15.5 and 18.5mm length for 7and 8 mm Ø)	Same as total length	Same as totallength		Same as totallength	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 andTitanium TI-6Al-4V ELI
	Implant Endosseous Surface	Aluminum oxide blasted andpassivated	Grit blasted and acid etched	Blasted with resorbable medium, oretched		Sand blasted and acid etched	MTX Blasted	Sand-blasted, Large grit, Acid-etched (SLA)
	Healing ComponentsCover screws, Healing caps,Healing cuffs	Coronal Ø: 3.25-8.0 mmGingival Height: 0-5 mmConnection: ThreadedTitanium Alloy (ASTM F136)	Healing ComponentsCoronal Ø: Not stated in summarConnection: HexTitanium Alloy (ASTM F136)	Healing ComponentsCoronal Ø: Narrow, Reg, WideConnection: HexTitanium Alloy (ASTM F136)		Healing ComponentsCoronal Ø: Not stated in summaryConnection: HexTitanium Alloy (ASTM F136)		Not stated in summary
	AbutmentsPost Abutment, PlatformSwitch, One-PieceAbutment, TemporaryAbutment	Coronal Ø: 3.25-5.0 mmGingival Height: 1.4-1.5 mmAngulation: 0°, 15°, 30°Connection: Pentagon or threadedTitanium Alloy (ASTM F136)	AbutmentsCoronal Ø: 3.3-5.0Angulation: 0°, 17°, 30°Connection: Internal hexTitanium Alloy (ASTM F136)	Taper Hex AbutmentsCoronal Ø: Narrow, Reg, WideAngulation: 0°, 15°, 25°, 30°Connection: HexTitanium Alloy (ASTM F136)		AbutmentsCoronal Ø: Not stated in summaryAngulation: 0°, 10°, 15°, 20°, 25°Connection: HexTitanium Alloy ELI (ASTM F136)		Coronal Ø: 4.0-10.0 mmLength: 8.4-16.4 mmAngulation: 0°, 15°, 25°Connection: Internal pentagonor threadedTitanium Alloy (ASTM F136)	Coronal Ø: 3.0 mmGingival Height: Not statedAngulation: 0°, 15°Connection: Internal HexTitanium Vanadium Alloy
	Ball Abutment	Coronal Ø: 4.0-5.25 mmGingival Height: 1-5 mmConnection: ThreadedTitanium Alloy (ASTM F136)Nylon and Silicone Inserts	Ball-type abutmentsCoronal Ø: 3.3-5.0Connection: HexTitanium Alloy (ASTM F136)	Overdenture AbutmentCoronal Ø: Narrow, Reg, WideConnection: ThreadedTitanium Alloy (ASTM F136)		Ball-type abutmentsCoronal Ø: Not stated in summaryConnection: Internal HexTitanium 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 ImplantSystemTatum Surgical	K133510Neodent Implant SystemJJGC Industria e Comercio deMateriais Dentarios SA	K102034Blue Sky Bio Dental Implant SystemBlue Sky Bio, LLC	K180282MIS Internal Hex Dental ImplantSystemMIS Implants Technologies Ltd.	K061410 (Advent)Zimmer Dental ImplantSystemZimmer Dental	K122231Xpeed AnyRidge InternalImplant SystemMegaGen Implant	K111581NobelActive 3.0 AngledAbutmentNobel Biocare USA, LLC	K092035Bicon Implants with 2.5 mmInternal ConnectionBicon 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 InterfaceConnection	Internal pentagon	Internal hex	Internal hexw/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, 5.0Titamax 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, 16Ø 3.75 - 8, 10, 11.5, 13, 16, 18, 20Ø 4.2-6, 8, 10, 11.5, 13, 16, 18, 20Ø 5.0-6, 8, 10, 11.5, 13, 16Ø 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, 5.9low 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, 17Titamax 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, 17.2Low 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 and8 mm Ø)	Same as total length	Same as totallength	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 andTitanium TI-6Al-4V ELI
Implant Endosseous Surface	Aluminum oxide blasted andpassivated	grit blasted and acid etched	Blasted with resorbable medium, oretched	Sand blasted and acid etched	MTX Blasted	Sand-blasted, Large grit, Acid-etched (SLA)
Healing ComponentsHealing screws, Healingcuffs	Coronal Ø: 2.5-8.0 mmGingival Height: 2.4-3.63 mmConnection: ThreadedTitanium Alloy (ASTM F136)	Cover Screws and HealingAbutmentsCoronal Ø: Not stated in summaryConnection: HexTitanium Alloy (ASTM F136)	Cover Screws and HealingAbutmentsCoronal Ø: Narrow, Reg, WideConnection: HexTitanium Alloy (ASTM F136)	Cover Screws and HealingAbutmentsCoronal Ø: Not stated in summaryConnection: HexTitanium Alloy (ASTM F136)		Not stated in summary
AbutmentsUnipost Abutment,Temporary Abutment	Coronal Ø: 3.0-7.0 mmGingival Height: 0-5 mmAngulation: 0°, 20°, 30°Connection: ThreadedTitanium Alloy (ASTM F136)	AbutmentsCoronal Ø: 3.3-5.0Angulation: 0°, 17°, 30°Connection: HexTitanium Alloy (ASTM F136)	Taper Hex AbutmentsCoronal Ø: Narrow, Reg, WideAngulation: 0°, 15°, 25°, 30°Connection: HexTitanium Alloy (ASTM F136)	AbutmentsCoronal Ø: Not stated in summaryAngulation: 0°, 10°, 15°, 20°, 25°Connection: HexTitanium Alloy ELI (ASTM F136)		Coronal Ø: 4.0-10.0 mmLength: 8.4-16.4 mmAngulation: 0°, 15°, 25°Connection: Internal pentagonor threadedTitanium Alloy (ASTM F136)	Coronal Ø: 3.0 mmGingival Height: Not statedAngulation: 0°, 15°Connection: Internal HexTitanium Vanadium Alloy
Ball Abutment	Coronal Ø: 3.5-4.5 mmGingival Height: 1-5 mmConnection: ThreadedTitanium Alloy (ASTM F136)Nylon and Silicone Inserts	Ball-type abutmentsCoronal Ø: 3.3-5.0Connection: HexTitanium Alloy (ASTM F136)	Overdenture AbutmentCoronal Ø: Narrow, Reg, WideConnection: ThreadedTitanium Alloy (ASTM F136)	Ball-type abutmentsCoronal Ø: Not stated in summaryConnection: HexTitanium Alloy (ASTM F136)Nylon Inserts		Not stated in summary
P Implants
Implant Placement	Bone level		Bone level	Bone level				Bone level
Prosthetic InterfaceConnection	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, 20Ø 5.0-6, 8, 10, 11.5, 13, 1606.0-6, 8, 10, 11.5, 13				Ø 4.0-5, 8, 11Ø 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

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	Subject Device	Primary Predicate	Additional Predicate	Additional Predicate	Additional Predicate	Additional Predicate	Additional Predicate	Additional Predicate
Feature	Tatum Surgical Dental ImplantSystemTatum Surgical	K133510Neodent Implant SystemJJGC Industria e Comercio deMateriais Dentarios SA	K102034Blue Sky Bio Dental Implant SystemBlue Sky Bio, LLC	K180282MIS Internal Hex Dental ImplantSystemMIS Implants Technologies Ltd.	K061410 (Advent)Zimmer Dental ImplantSystemZimmer Dental	K122231Xpeed AnyRidge InternalImplant SystemMegaGen Implant	K111581NobelActive 3.0 AngledAbutmentNobel Biocare USA, LLC	K092035Bicon Implants with 2.5 mmInternal ConnectionBicon 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 andpassivated		Blasted with resorbable medium, oretched	Sand blasted and acid etched				Grit blasted, acid etched,and hydroxylapatite
Healing ComponentsHealing Abutments	Coronal Ø: 4.5-5.0 mmConnection: MorseTitanium Alloy (ASTM F136)		Cover Screws and HealingAbutmentsCoronal Ø: Narrow, Reg, WideConnection: HexTitanium Alloy (ASTM F136)	Coronal Ø: Not stated in summaryConnection: HexTitanium Alloy (ASTM F136)
AbutmentNon-shouldered Abutment,Shouldered Abutment	Coronal Ø: 4.5-5.0 mmGingival Height: 2-6 mmAngulation: 0°, 15°Connection: MorseTitanium Alloy (ASTM F136)		Taper Hex AbutmentsCoronal Ø: Narrow, Reg, WideAngulation: 0°, 15°, 25°, 30°Connection: HexTitanium Alloy (ASTM F136)	Coronal Ø: Not stated in summaryAngulation: 0°, 10°, 15°, 20°, 25°Connection: HexTitanium Alloy ELI (ASTM F136)
Ball Abutment	Coronal Ø: 4.5-5.0 mmGingival Height: 1.5-3.5 mmConnection: MorseTitanium Alloy (ASTM F136)Nylon and Silicone Inserts		Overdenture AbutmentCoronal Ø: Narrow, Reg, WideConnection: ThreadedTitanium Alloy (ASTM F136)	Coronal Ø: Not stated in summaryConnection: HexTitanium Alloy (ASTM F136)Nylon Inserts
How Provided
Sterility	Sterile implants, nonsterile abutments	Sterile implants, nonsterileabutments	Sterile implants, nonsterileabutments	Sterile implants, nonsterileabutments	Sterile implants	Sterile implants, nonsterileabutments	Nonsterile abutments	Sterile implants, nonsterileabutments
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

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	Subject Device	Additional Predicate	Additional Predicate	Additional Predicate	Additional Predicate
Feature	Tatum Surgical	K171728MOR 3.0mm andPUR NP 3.2mmImplant Systems,MOR 2.1 x 18mmand 2.4x18mmSterngold Dental,LLC	K071235 (3.0 angled),K063523 (3.7 & 4.7straight & angled)K052997 (3.0 and 3.7straight)Zimmer One-PieceZimmer Dental, Inc.	K093595CeraRoot ImplantSystemOral Iceberg S.L.	K110548OSI O-ball AbutmentDental ImplantJuell Dental
Product Code	DZE, NHA	DZE, NHA	DZE, NHA	DZE, NHA	DZE, NHA
Reason forPredicate/Reference Device	n/a	Straight & BallAbutmentNarrow x short(2.1x10)Narrow x long(2.1&18)	Straight & AngledAbutmentNarrow x short(3.0x10)	Straight AbutmentWide x short (6.5x8)Wide x long (6.5x14)	Ball AbutmentWide x long (4.5x18)
One-PieceImplants,StraightAbutment	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/PlatformDiameter, 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
EndosseousLengths, 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 titanium6AL-4VELI	Titanium alloy(Ti6Al-4V)	Zirconia
ImplantEndosseousSurface	Aluminum Oxide(Al2O3) Blasted,passivated	Roughened - blastedand acidEtched	Grit blasted	None
Abutment	Straight	Straight	Straight	Straight
One-PieceImplants, AngledAbutment	Image: One-Piece Implants, Angled Abutment
Body/PlatformDiameter, mm	3.0, 3.5, 4.0, 4.5		3.0, 3.7, 4.7
EndosseousLength, mm	14, 17		10, 11.5, 13, 16 (no 16for 3.0)
Abutment Collar,mm	1.5		0.5
Implant Material	Titanium alloy(Ti6Al-4V)		Titanium alloy(Ti6Al-4V)
ImplantEndosseousSurface	Aluminum Oxide(Al2O3) Blasted,passivated		Grit blasted
	Subject Device	AdditionalPredicate	Additional Predicate	Additional Predicate	Additional Predicate
Feature	Tatum Surgical	K171728MOR 3.0mm andPUR NP 3.2mmImplant Systems,MOR 2.1 x 18mmand 2.4x18mmSterngold Dental,LLC	K071235 (3.0 angled),K063523 (3.7 & 4.7straight & angled)K052997 (3.0 and 3.7straight)Zimmer One-PieceZimmer Dental, Inc.	K093595CeraRoot ImplantSystemOral Iceberg S.L.	K110548OSI O-ball AbutmentDental ImplantJuell Dental
One-PieceImplants withBall Abutment	Image: Tatum Surgical Implant	Image: K171728 Implant	Image: K071235 Implant		Image: K110548 Implant
Body/PlatformDiameter, 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
EndosseousLengths, 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 titanium6AL-4V ELI			Titanium alloy (Ti6Al-4V) F136
ImplantEndosseousSurface	Aluminum Oxide(Al2O3) Blasted,passivated	Roughened - blastedand acidetched			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

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Regulation Number and Section

§ 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.