(116 days)
No
The document describes various dental implants, abutments, and screws, which are physical devices. There is no mention of software, algorithms, image processing, AI, or ML.
Yes
The device, which includes implants, abutments, and copings, is intended to be surgically placed to support prosthetic devices, restore chewing function, and aid in orthodontic movement and bone regeneration. These actions directly address medical conditions or provide support for bodily functions, classifying it as a therapeutic device.
No
This device is described as an implant system and associated components (abutments, copings) intended to be surgically placed in the bone to support prosthetic devices and restore chewing function. It also includes devices for temporary orthodontic anchorage and bone graft fixation. None of these uses involve diagnosing a condition.
No
The document describes various physical dental implants, abutments, copings, and screws, which are hardware devices intended for surgical placement. There is no mention of software as the primary or sole component of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Intended Use: The intended use of the devices described is clearly focused on being surgically placed in the bone of the jaw to support prosthetic devices for restoring chewing function. This is a surgical and prosthetic application, not an in vitro diagnostic test.
- Anatomical Site: The anatomical sites mentioned (bone of the upper or lower jaw, zygoma region, oral cavity) are where the devices are implanted or used directly on the patient, not where specimens are collected for testing.
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens.
- Providing diagnostic information.
- Using reagents or assays.
- Measuring biomarkers.
The devices described are dental implants, abutments, copings, and related components used in restorative dentistry and orthodontics. These are considered medical devices, but not IVDs.
N/A
Intended Use / Indications for Use
- HE (External Hex) implants, stock abutments and stock copings (originally cleared per K101207)
- Titamax CM (Cone Morse) implants, stock abutments and stock copings (originally cleared per K101945 ● and extended per K123022, K133696 and K150199)
- Titamax CM (Cone Morse) EX implants, stock abutments and stock copings (originally cleared per K101945 and extended per K123022, K133696 and K150199)
- Alvim CM (Cone Morse) implants, stock abutments and stock copings (originally cleared per K101945 and ● extended per K123022, K133696 and K150199)
- CM (Cone Morse) Drive implants, stock abutments and stock copings (originally cleared per K123022 and extended per K133696, K150182 and K150199)
- GM (Grand Morse) Titamax implants, stock abutments and stock copings (originally cleared per K163194)
- GM (Grand Morse) Drive implants, stock abutments and stock copings (originally cleared per K163194) ●
- . GM (Grand Morse) Helix implants, stock abutments and stock copings (originally cleared per K163194)
The implants, abutments and copings of the Neodent Implant System are 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.
- Titamax WS implants, abutments and copings (originally cleared per K123022)
The implants, abutments and copings of the Neodent Implant System are 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. The Neodent Implant System may be used for single or multiple unit restorations. Multiple tooth applications may be rigidly splinted.
The Titamax WS implants are indicated for a delayed loading protocol.
- Facility implants, stock abutments and stock copings (originally cleared per K123022 and extended per K133696 and K150199)
The implants, abutments and copings of the Neodent Implant System are 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. The Neodent Implant System may be used for single or multiple unit restorations. Multiple tooth applications may be rigidly splinted.
The Facility implants of the Neodent Implant System are indicated for replacement of maxillary lateral incisors, mandibular incisors or retention of overdentures.
- Zygomatic implants, stock abutments and stock copings (originally cleared per K141777)
The Zygomatic implants, abutments and copings of the Neodent Implant System are 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.
The Zygomatic implants of the Neodent Implant System are indicated for surgical installation in the zygoma region in cases of severe jaw resorption in order to restore patient esthetics and chewing function. Zygomatic implants are recommended for the posterior (pre-molar/ molar) region, one implant on each side, with at least two standard dental implants in the anterior region to support a fixed restoration.
- CM (Cone Morse) Titanium Base Abutment component of two-piece patient-specific abutment (originally cleared per K150367 and extended per K153624)
- o GM (Grand Morse) Exact Titanium Base Abutment component of two-piece patient-specific abutment (originally cleared per K163194)
The implants, abutments and copings of the Neodent Implant System are 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.
The Titanium Base Abutment is a titanium base placed onto Neodent dental implants to provide support for customized prosthetic restorations. The Titanium Base is used with a coping and crown, or crown alone, and is indicated for cement-retained single or multi-unit restorations, or screw-retained single restorations.
All digitally designed copings and/or crowns for use with the Neodent Titanium Base Abutment are intended to be sent to Straumann for manufacture at a validated milling center.
- CM (Cone Morse) Titanium Base for CEREC Abutment component of two-piece patient-specific abutment (originally cleared per K160964)
The implants, abutments and copings of the Neodent Implant System are 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.
The Titanium Base for CEREC Abutment is a titanium base placed onto Neodent dental implants to provide support for customized prosthetic restorations. They are used with a coping and crown, or crown alone, and is indicated for cement-retained single or multi-unit restorations, or screw-retained single restorations.
All digitally designed copings and/or crowns for use with the Neodent Titanium Base for CEREC Abutment are to be designed using Sirona inLab software or Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit.
- CM Preface Abutment component of patient-specific abutment (originally cleared per K150367)
The implants, abutments and copings of the Neodent Implant System are 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.
The Preface Abutment is a titanium abutment to be used in fabricating a full custom abutment placed onto Neodent dental implants to provide support for customized prosthetic restorations. The Preface Abutments is indicated for screw-retained single restorations or cement-retained single or multi-unit restorations.
All digitally designed restorations for use with the Neodent Preface Abutment are intended to be sent to Straumann for manufacture at a validated milling center.
- GM (Grand Morse) ProPEEK Abutments (originally cleared per K163194) ●
- CM (Cone Morse) ProPEEK Abutments (originally cleared per K170080)
The implants, abutments and copings of the Neodent Implant System are 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.
The Pro PEEK Abutment is indicated to be used on Neodent implants to provide temporary support for prosthesis structure for up to 6 months.
-
Neodent Implant for Orthodontic Anchor (originally cleared per K102769) ●
The Neodent Implant for Orthodontic Anchor is a surgical device in the form of a temporary screw used as an aid in orthodontic movement procedures. -
. The Neodent Graft Screw (originally cleared per K103084)
The Neodent Graft Screw is an implantable device used for fixation of bone blocks for the regeneration of bone in the oral cavity. The product is intended for temporary use only.
Product codes
DZE, NHA
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper or lower jaw, zygoma region, oral cavity
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
K101207, K101945, K123022, K133696, K150199, K150182, K163194, K141777, K150367, K153624, K160964, K170080, K102769, K103084
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
JJGC Industria e Comercio de Materiais Dentarios SA % Jennifer Jackson Director of Regulatory Affairs and Quality Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810
January 18,2019
Re: K182620
Trade/Device Name: MRI Compatibility for Existing Neodent Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: October 19, 2018 Received: October 22, 2018
Dear Jennifer Jackson:
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.
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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by Mary S. Mary S. Runner -S3 Runner -S3 Date: 2019.01.18
15:30:27 -05'00'
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known) K182620
Device Name
MRI Compatibility for Existing Neodent Implant System Devices
Indications for Use (Describe)
- HE (External Hex) implants, stock abutments and stock copings (originally cleared per K101207)
- Titamax CM (Cone Morse) implants, stock abutments and stock copings (originally cleared per K101945 ● and extended per K123022, K133696 and K150199)
- Titamax CM (Cone Morse) EX implants, stock abutments and stock copings (originally cleared per K101945 and extended per K123022, K133696 and K150199)
- Alvim CM (Cone Morse) implants, stock abutments and stock copings (originally cleared per K101945 and ● extended per K123022, K133696 and K150199)
- CM (Cone Morse) Drive implants, stock abutments and stock copings (originally cleared per K123022 and extended per K133696, K150182 and K150199)
- GM (Grand Morse) Titamax implants, stock abutments and stock copings (originally cleared per K163194)
- GM (Grand Morse) Drive implants, stock abutments and stock copings (originally cleared per K163194) ●
- . GM (Grand Morse) Helix implants, stock abutments and stock copings (originally cleared per K163194)
The implants, abutments and copings of the Neodent Implant System are 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.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
3
510(k) Number (if known)
Device Name
MRI Compatibility for Existing Neodent Implant System Titamax WS Devices
Indications for Use (Describe)
- Titamax WS implants, abutments and copings (originally cleared per K123022)
The implants, abutments and copings of the Neodent Implant System are 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. The Neodent Implant System may be used for single or multiple unit restorations. Multiple tooth applications may be rigidly splinted.
The Titamax WS implants are indicated for a delayed loading protocol.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
4
510(k) Number (if known)
Device Name
MRI Compatibility for Existing Neodent Implant System Facility Devices
Indications for Use (Describe)
- Facility implants, stock abutments and stock copings (originally cleared per K123022 and extended per K133696 and K150199)
The implants, abutments and copings of the Neodent Implant System are 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. The Neodent Implant System may be used for single or multiple unit restorations. Multiple tooth applications may be rigidly splinted.
The Facility implants of the Neodent Implant System are indicated for replacement of maxillary lateral incisors, mandibular incisors or retention of overdentures.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
5
510(k) Number (if known)
Device Name
MRI Compatibility for Existing Neodent Implant System Zygomatic Implant Devices
Indications for Use (Describe)
- Zygomatic implants, stock abutments and stock copings (originally cleared per K141777)
The Zygomatic implants, abutments and copings of the Neodent Implant System are 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.
The Zygomatic implants of the Neodent Implant System are indicated for surgical installation in the zygoma region in cases of severe jaw resorption in order to restore patient esthetics and chewing function. Zygomatic implants are recommended for the posterior (pre-molar/ molar) region, one implant on each side, with at least two standard dental implants in the anterior region to support a fixed restoration.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
6
510(k) Number (if known)
Device Name
MRI Compatibility for Existing Neodent Implant System Titanium Base Abutment Devices
Indications for Use (Describe)
- CM (Cone Morse) Titanium Base Abutment component of two-piece patient-specific abutment (originally cleared per K150367 and extended per K153624)
- o GM (Grand Morse) Exact Titanium Base Abutment component of two-piece patient-specific abutment (originally cleared per K163194)
The implants, abutments and copings of the Neodent Implant System are 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.
The Titanium Base Abutment is a titanium base placed onto Neodent dental implants to provide support for customized prosthetic restorations. The Titanium Base is used with a coping and crown, or crown alone, and is indicated for cement-retained single or multi-unit restorations, or screw-retained single restorations.
All digitally designed copings and/or crowns for use with the Neodent Titanium Base Abutment are intended to be sent to Straumann for manufacture at a validated milling center.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
7
510(k) Number (if known)
Device Name
MRI Compatibility for Existing Neodent Implant System Titanium Base for CEREC Abutment Devices
Indications for Use (Describe)
- CM (Cone Morse) Titanium Base for CEREC Abutment component of two-piece patient-specific abutment (originally cleared per K160964)
The implants, abutments and copings of the Neodent Implant System are 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.
The Titanium Base for CEREC Abutment is a titanium base placed onto Neodent dental implants to provide support for customized prosthetic restorations. They are used with a coping and crown, or crown alone, and is indicated for cement-retained single or multi-unit restorations, or screw-retained single restorations.
All digitally designed copings and/or crowns for use with the Neodent Titanium Base for CEREC Abutment are to be designed using Sirona inLab software or Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
8
510(k) Number (if known) K182620
Device Name
MRI Compatibility for Existing Neodent Implant System Preface Abutment Devices
Indications for Use (Describe)
- CM Preface Abutment component of patient-specific abutment (originally cleared per K150367)
The implants, abutments and copings of the Neodent Implant System are 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.
The Preface Abutment is a titanium abutment to be used in fabricating a full custom abutment placed onto Neodent dental implants to provide support for customized prosthetic restorations. The Preface Abutments is indicated for screw-retained single restorations or cement-retained single or multi-unit restorations.
All digitally designed restorations for use with the Neodent Preface Abutment are intended to be sent to Straumann for manufacture at a validated milling center.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
9
510(k) Number (if known)
Device Name
MRI Compatibility for Existing Neodent Implant System ProPEEK Abutment Devices
Indications for Use (Describe)
- GM (Grand Morse) ProPEEK Abutments (originally cleared per K163194) ●
- CM (Cone Morse) ProPEEK Abutments (originally cleared per K170080)
The implants, abutments and copings of the Neodent Implant System are 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.
The Pro PEEK Abutment is indicated to be used on Neodent implants to provide temporary support for prosthesis structure for up to 6 months.
Type of Use (Select one or both, as applicable)
|X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
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510(k) Number (if known) K182620
Device Name
MRI Compatibility for Existing Neodent Implant System Orthodontic Anchor Devices
Indications for Use (Describe)
- Neodent Implant for Orthodontic Anchor (originally cleared per K102769) ●
The Neodent Implant for Orthodontic Anchor is a surgical device in the form of a temporary screw used as an aid in orthodontic movement procedures.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
11
510(k) Number (if known)
Device Name
MRI Compatibility for Existing Neodent Implant System Graft Screw Devices
Indications for Use (Describe)
- . The Neodent Graft Screw (originally cleared per K103084)
The Neodent Graft Screw is an implantable device used for fixation of bone blocks for the regeneration of bone in the oral cavity. The product is intended for temporary use only.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov