(150 days)
The CreoDent Solidex® Customized Abutment is intended for use with an endosseous implant to support a prosthetic device in patients who are partially or completely endentulous. The device can be used for sinqle or multiple-unit restorations. The prosthesis can be cemented or screw retained to the abutment. An abutment screw is used to secure the abutment to the endosseous implant.
The CreoDent Solidex® Customized Abutment is compatible with the following:
- . Biomet 3i Osseotite Certain Dental Implants 3.25mm, 4.0mm, 5.0mm, 6.0mm
- o Straumann Bone Level Implants 3.3mm. 4.1mm. 4.8mm
The Solidex® Customized Abutment is Ti-6A1-4V Eli titanium alloy meets ASTM F-136 Standard and Screw is CP TI Gr4 meets ASTM F67 and is designed to be screw retained for use with endosseous dental implants to provide support for a prosthetic restoration. These abutments are indicated for cement or screw retained restorations. Solidex® Customized Abutments are compatibe with:
- Biomet 3i Osseotite Certain 3.25mm, 4.0mm, 6.0mm diameter implants K063341 .
- Straumann Bone Level implants 3.3mm, 4.1mm, 4.8mm K083550 K121131 .
The design of subject device is customized to the requirements of each patient as may be specified by the prescribing dentist. Customization is limited by the minimum dimensions for wall thickness, diameter, height, collar height and angulation.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the CreoDent Solidex® Customized Abutment:
Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a traditional clinical trial report with specific acceptance criteria as might be found for a novel device. The "acceptance criteria" here are implicitly related to demonstrating performance equivalence to the predicate devices through non-clinical testing.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of this 510(k) summary, the "acceptance criteria" are the demonstration of equivalent or superior performance to the predicate devices through specific non-clinical tests. The reported device performance is that these tests showed sufficient strength and compatibility.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Mechanical Strength (Fatigue Testing): Device maintains structural integrity and function under dynamic loading conditions, comparable to or better than predicate devices. | "Static/Fatigue testing was conducted in accordance with ISO 14801:2007E Dentistry-Implants-Dynamic fatigue test for endosseous dental implants with the worst case scenario..." demonstrated "sufficient mechanical strength for their intended clinical application." |
| Dimensional Compatibility: Device fits correctly and securely with specified implant systems. | "Reverse engineering dimensional analysis using compatible implant fixtures..." confirmed compatibility. |
| Sterilization Efficacy: Sterilization process is effective in rendering the device sterile. | "Sterilization validation according to ISO 17665-1 was performed." |
| Material Equivalence/Superiority: Material properties are suitable for the intended use and are equivalent or superior to predicate devices. | Abutment is Ti-6A1-4V Eli titanium alloy (ASTM F-136 Standard), which is a "higher grade material with more tensile strength" than the primary predicate's CP Ti Gr4 (ASTM F67). Screw is CP Ti Gr4 (ASTM F67), same as predicate. Differences were mitigated by fatigue testing. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical laboratory testing, not human or animal clinical trials. Therefore, the concept of a "test set" in the context of clinical data or AI systems does not directly apply.
- Sample Size for Testing: The document does not specify the exact number of abutments or implants tested in the static/fatigue testing, dimensional analysis, or sterilization validation. It refers to these as "testing" or "analysis" without numerical details on the quantity of items used.
- Data Provenance: The data comes from non-clinical laboratory testing conducted by the manufacturer, CreoDent Prosthetics, Ltd. There is no information regarding country of origin of data beyond the manufacturer's location in New York, USA, or whether it's retrospective or prospective, as it's not a clinical study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable. The "ground truth" for this device's performance is established through internationally recognized engineering standards (ISO 14801:2007E, ISO 17665-1) and direct physical/mechanical testing, not through expert clinical consensus or interpretation of images/data by human experts.
4. Adjudication Method for the Test Set
This section is not applicable. As the testing is non-clinical and based on objective engineering measurements and standards, there is no need for an adjudication method involving human experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices or AI algorithms that rely on human interpretation of outputs. The CreoDent Solidex® Customized Abutment is a physical medical device (dental implant abutment), not a diagnostic or AI software.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This device is a physical product, not an algorithm or AI software.
7. The Type of Ground Truth Used
The "ground truth" for demonstrating the safety and effectiveness of the CreoDent Solidex® Customized Abutment is based on:
- Engineering Standards and Specifications: Adherence to ISO standards (ISO 14801:2007E for fatigue, ISO 17665-1 for sterilization) and ASTM material standards (ASTM F-136, ASTM F67).
- Objective Mechanical and Physical Measurements: Results from static/fatigue testing and reverse engineering dimensional analysis.
- Comparison to Predicate Devices: Demonstrating that the subject device's performance, materials, and indications for use are substantially equivalent to legally marketed predicate devices.
8. The Sample Size for the Training Set
This section is not applicable. The device is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
This section is not applicable for the same reason as above; there is no training set for a physical medical device.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three abstract human profiles facing right, with flowing lines extending from the bottom profile.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 4, 2015
CreoDent Prosthetics, Ltd. Mr. Calvin Shim Managing Director 29 West 30th Street, 11th Floor New York, New York 10001
Re: K150012
Trade/Device Name: CreoDent Solidex® Customized Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: May 4, 2015 Received: May 5, 2015
Dear Mr. Shim:
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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina
Kiang-S
for Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Premarket Notification Section 4: Page - 10
Indications for Use
510(k) Number (if known)___K150012
Device Name: CreoDent Solidex® Customized Abutment
Indication for Use:
The CreoDent Solidex® Customized Abutment is intended for use with an endosseous implant to support a prosthetic device in patients who are partially or completely endentulous. The device can be used for sinqle or multiple-unit restorations. The prosthesis can be cemented or screw retained to the abutment. An abutment screw is used to secure the abutment to the endosseous implant.
The CreoDent Solidex® Customized Abutment is compatible with the following:
- . Biomet 3i Osseotite Certain Dental Implants 3.25mm, 4.0mm, 5.0mm, 6.0mm
- o Straumann Bone Level Implants 3.3mm. 4.1mm. 4.8mm
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-the-Counter Use_____________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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510(k) Summary
CreoDent Prosthetics, Ltd. Solidex® Customized Abutment
Submitter Information
Company Name: Company Address:
Company Telephone: Company Fax: Contact Person:
CreoDent Prosthetics, Ltd. 29 West 30th Street, 11th Floor New York, New York 10001 (212) 302-3860 (212) 302-3865 Calvin Shim (212) 302-3860 June 4, 2015
Date Summary Prepared:
DEVICE NAME AND CLASSIFICATION
Trade/Proprietary Name: Common Name:
Product Code: Classification Panel: Reviewing Branch:
CreoDent Solidex® Customized Abutment Endosseous Dental Implant Abutment 21 CFR 872.3630 NHA Dental Products Panel Dental Devices Branch
INDICATIONS FOR USE
The CreoDent Solidex® Customized Abutment is intended for use with an endosseous implant to support a prosthetic device in patients who are partially or completely endentulous. The device can be used for single or multiple-unit restorations. The prosthesis can be cemented or screw retained to the abutment. An abutment screw is used to secure the abutment to the endosseous implant.
The CreoDent Solidex® Customized Abutment is compatible with the following:
- . Biomet 3i Osseotite Certain Dental Implants 3.25mm, 4.0mm, 5.0mm, 6.0mm..
- . Straumann Bone Level implants 3.3mm, 4.1mm, 4.8mm
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DEVICE DESCRIPTION
The Solidex® Customized Abutment is Ti-6A1-4V Eli titanium alloy meets ASTM F-136 Standard and Screw is CP TI Gr4 meets ASTM F67 and is designed to be screw retained for use with endosseous dental implants to provide support for a prosthetic restoration. These abutments are indicated for cement or screw retained restorations. Solidex® Customized Abutments are compatibe with:
- Biomet 3i Osseotite Certain 3.25mm, 4.0mm, 6.0mm diameter implants K063341 .
- Straumann Bone Level implants 3.3mm, 4.1mm, 4.8mm K083550 K121131 .
The design of subject device is customized to the requirements of each patient as may be specified by the prescribing dentist. Customization is limited by the minimum dimensions for wall thickness, diameter, height, collar height and angulation.
EQUIVALENCE TO MARKETED DEVICE
The CreoDent Solidex® Customized Abutments are substantially equivalent in intended use, material. design and performance to:
- . Primary Predicate
- Creodent Solidex Customlized Abutments (K113738) о
- . Reference Predicates
Conclusion:
The Creodent Solidex® Customized Abutments are substantially equivalent to the identified predicate products noted in this 510K Summary.
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| TechnologicalCharacteristics | CreoDent Solidex® CustomizedAbutment and Abutment Screw | Primary Predicate Device forclaimed equivalence: CreodentSolidex Customized Abutment(K113738) |
|---|---|---|
| Material | Abutment is Ti-6A1-4V Eli titanium alloymeets ASTM F-136 Standard. It is a highergrade material with more tensile strength.The Screw is CP TI Gr4 meets ASTM F67Standard. | -Abutment and Screw: are CP Ti Gr4and meets ASTM F67 standard.The Screw is exactly the sametitanium alloy but the abutment is alower grade(less tensile strength)titanium alloy compared to Ti-6A1-4VASTM F-136 standard. |
| PerformanceCharacteristics | Allows the prosthesis to be cemented orscrew retained to the abutment. Theabutment screw is designed to secure theabutment to the endosseous implant. | Allows the prosthesis to be cementedor screw retained to the abutment. Theabutment screw is designed to securethe abutment to the endosseousimplant. |
| Indications forUse | The CreoDent Solidex® CustomizedAbutment is intended for use with anendosseous implant to support a prostheticdevice in patients who are partially orcompletely edentulous. The device can beused for single or multiple-unit restorations.The prosthesis can be cemented or screwretained to the abutment. An abutment screwis used to secure the abutment to theendosseous implant.The CreoDent Solidex® CustomizedAbutment is compatible with the following:Biomet 3i Osseotite Certain DentalImplants 3.25mm, 4mm, 5mm, 6mm Straumann Bone Level implants3.3mm, 4.1mm, 4.8mm | The CreoDent Solidex® CustomizedAbutment is intended for use with anendosseous implant to support aprosthetic device in patients who arepartially or completely endentulous. Thedevice can be used for single or multiple-unit restorations. The prosthesis can becemented or screw retained to theabutment. An abutment screw is used tosecure the abutment to the endosseousimplant.The CreoDent Solidex® CustomizedAbutment is compatible with the following:Nobel Replace™ TiUnite Endosseous3.5mm (NP), 4.3mm (RP), and 5.0mm(WP) diameter implants.Nobel Active™ Internal Connection3.5mm (NP) and 4.3mm (RP) diameterimplants. Zimmer Screw-Vent 3.7mm,4.7mm; Zimmer Tapered Screw-Vent3.7mm (NP), 4.7mm (RP) and 6.0mmdiameter implants. |
| DimensionsandAngulations | Creodent Solidex Customized Abutment sizesfor Biomet 3i Osseotite Certain 3.25mm,4.0mm, 5.0mm and 6.0mm diameter implants.Straumann Bone Level implants 3.3mm,4.1mm, 4.8mmAngles not to exceed up to 20 degrees from | Abutment sizes for Nobel Replace™TiUnite Endosseous 3.5mm (NP), 4.3mm(RP), and 5.0mm (WP) diameter implants.Nobel Active™ Internal Connection3.5mm (NP) and 4.3mm (RP) diameterimplants. Zimmer Screw-Vent 3.7mm,4.7mm; Zimmer Tapered Screw-Vent3.7mm (NP), 4.7mm (RP) and 6.0mm |
| the implant axis. | diameter implants. | |
| Angles not to exceed up to 20 degreesfrom the implant axis. |
Table #1 Legally marketed predicate device (Abutment) to which equivalence is claimed:
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Non-clinical Testing Data: Static/Fatigue testing was conducted in accordance with ISO 14801:2007E Dentisty-Implants-Dynamic fatigue test for endosseous dental implants with the worst case scenario for the Solidex® Customized Abutment connection platform. Reverse engineering dimensional analysis using compatible implant fixtures and sterilization validation according to ISO 17665-1 was performed. These results demonstrated that the Solidex® customized Abutment have sufficient mechanical strength for their intended clinical application and are compatible with the Biomet 3i Osseotite Certain and Straumann Bone level Dental implant system for which they are intended.
Substantial Equivalence discussion: The difference between the subject device and the Primary predicate is the compatible implant bodies. This difference is mitigated by fatigue testing, reverse engineering dimensional analysis, and identification of reference predicate for compatible implant bodies. The difference between the subiect device and the primary predicate abutment is the titanium grade. The subject device is a higher grade titanium alloy that exhibits higher tensile strength. The difference is mitigated by fatigue testing. The screw material is exactly the same.
| TechnologicalCharacteristics | CreoDent Solidex® CustomizedAbutment and Abutment Screw | Reference Predicate Device forclaimed equivalence: Biomet 3iEncode Patient Specific DentalAbutment (K101608) |
|---|---|---|
| Material | Abutment is Ti-6A1-4V Eli titanium alloymeets ASTM F-136 Standard and Screw isCP TI Gr4 meets ASTM F67 Standard | -Abutment and Screw: ComparableTitanium Alloy |
| PerformanceCharacteristics | Allows the prosthesis to be cemented orscrew retained to the abutment. Theabutment screw is designed to secure theabutment to the endosseous implant. | Allows the prosthesis to be cementedor screw retained to the abutment. Theabutment screw is designed to securethe abutment to the endosseousimplant. |
| Indications forUse | The CreoDent Solidex® CustomizedAbutment is intended for use with anendosseous implant to support a prostheticdevice in patients who are partially orcompletely edentulous. The device can beused for single or multiple-unit restorations.The prosthesis can be cemented or screwretained to the abutment. An abutment screwis used to secure the abutment to theendosseous implant.The CreoDent Solidex® CustomizedAbutment is compatible with the following:• Biomet 3i Osseotite Certain DentalImplants 3.25mm, 4mm, 5mm, 6mm | Encode Patient Specific Dentalabutments made from Oral scansprovided from Lava Chair Scannerand the 3M lava COS (2.0) softwareare intended for use as an accessory toendosseous dental implants to supporta prosthetic device in a partially oredentulous patient. Encode Patientspecific dental abutments are intendedfor use to support single and multipletooth prostheses, in the mandible ormaxilla. The prostheses can be screwor cement retained. |
| Dimensions | Creodent Solidex Customized Abutment sizes | Biomet 3i Encode Abutment sizes for |
Table #2 Legally marketed predicate device (Abutment) to which equivalence is claimed:
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| andAngulations | for Biomet 3i Osseotite Certain 3.25mm,4.0mm, 5.0mm and 6.0mm diameter implants.Angles not to exceed up to 20 degrees fromthe implant axis. | Biomet 3i Osseotite Certain 3.25mm,4.0mm, 5.0mm, 6.0mm diameterimplants.Angles not to exceed up to 30 degreesfrom the implant axis. |
|---|---|---|
| -------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------- |
Non-clinical Testing Data: Static/Fatigue testing was conducted in accordance with ISO 14801:2007E Dentistry-Implants-Dynamic fatigue test for endosseous dental implants with the worst case scenario for the Solidex® Customized Abutment connection platform. Reverse engineering dimensional analysis using compatible implant fixtures and sterilization validation according to ISO 17665-1 was performed.These results demonstrated that the Solidex® customized Abutment have sufficient mechanical strength for their intended clinical application and are compatible with the Biomet 31 Osseotite Certain Dental implant system for which they are intended.
Substantial Equivalence discussion: The difference between the subject device and the reference predicate is the angulation. This difference is mitigated by fatigue testing, reverse engineering dimensional analysis.
| TechnologicalCharacteristics | CreoDent Solidex® CustomizedAbutment and Abutment Screw | Reference Predicate Device forclaimed equivalence: StraumannCares Titanium Abutment(K082764) |
|---|---|---|
| Material | Abutment is Ti-6A1-4V Eli titanium alloymeets ASTM F-136 Standard and Screw isCP TI Gr4 meets ASTM F67 Standard | -Abutment and Screw: ComparableTitanium |
| PerformanceCharacteristics | Allows the prosthesis to be cemented orscrew retained to the abutment. Theabutment screw is designed to secure theabutment to the endosseous implant. | Allows the prosthesis to be cementedor screw retained to the abutment. Theabutment screw is designed to securethe abutment to the endosseousimplant. |
| Indications forUse | The CreoDent Solidex® CustomizedAbutment is intended for use with anendosseous implant to support a prostheticdevice in patients who are partially orcompletely edentulous. The device can beused for single or multiple-unit restorations.The prosthesis can be cemented or screwretained to the abutment. An abutment screwis used to secure the abutment to theendosseous implant.The CreoDent Solidex® CustomizedAbutment is compatible with the following:Straumann Bone Level implants3.3mm, 4.1mm, 4.8mm | Abutments are placed into the dentalimplants to provide support forprosthetic restoration such as crownsor bridges. The Straumann WN CaresTitanium Abutment is indicated forsingle tooth replacement and multipletooth restorations. The prostheticrestoration is cement retained. |
| Dimensionsand | Solidex Abutment sizes for Straumann BoneLevel implants 3.3mm, 4.1mm, 4.8mm | Straumann Cares Abutment sizes forStraumann Bone Level implants 3.3mm,4.1mm, 4.8mm |
Table #3 Legally marketed predicate device (Abutment) to which equivalence is claimed:
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| Angulations | Angles not to exceed up to 20 degrees from the implant axis. | Angles not to exceed up to 30 degrees from the implant axis. |
|---|---|---|
| ------------- | -------------------------------------------------------------- | -------------------------------------------------------------- |
Non-clinical Testing Data: Static/Fatigue testing was conducted in accordance with ISO 14801:2007E Dentisty-Implants-Dynamic fatigue test for endosseous dental implants with the worst case scenario for the Solidex® Customized Abutment connection platform. Reverse engineering dimensional analysis using compatible implant fixtures and sterilization validation according to ISO 17665-1 was performed. These results demonstrated that the Solidex® customized Abutment have sufficient mechanical strength for their intended clinical and are compatible with the Straumann Bone Level implant system for which they are intended.
Substantial Equivalence discussion: The difference between the subject device and the reference predicate is the angulation. This difference is mitigated by fatigue testing, reverse engineering dimensional analysis.
Table #3 Legally marketed predicate device (Implant) to which compatibility is claimed for the Solidex® Customized Abutment:
| Compatible Device | Implant Diameters | Implant Lengths |
|---|---|---|
| Biomet 3i Osseotite Certainimplants. (K063341) | 3.25mm | 8.5mm |
| 3.25mm | 10.0mm | |
| 3.25mm | 11.5mm | |
| 3.25mm | 13mm | |
| 3.25mm | 15mm | |
| Biomet 3i Osseotite Certaindental implants. (K063341) | 4.0mm | 8.5mm |
| 4.0mm | 10.0mm | |
| 4.0mm | 11.5mm | |
| 4.0mm | 13mm | |
| 4.0mm | 15mm | |
| Biomet 3i Osseotite Certaindental implants. (K063341) | 5.0mm | 8.5mm |
| 5.0mm | 10.0mm | |
| 5.0mm | 11.5mm | |
| 5.0mm | 13mm | |
| 5.0mm | 15mm | |
| Biomet 3i Osseotite CertainDental Implants (K063341) | 6.0mm | 8.5mm |
| 10.0mm | ||
| 11.5mm | ||
| 13mm | ||
| 15mm |
Table #4 Legally marketed predicate device (Implant) to which compatibility is claimed for the Solidex® Customized Abutment:
| Compatible Device | Implant Diameters | Implant Lengths |
|---|---|---|
| ------------------- | ------------------- | ----------------- |
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Premarket Notification Section 5: Page 11
| Straumann Bone Level implants(K083550) | 3.3mm3.3mm3.3mm3.3mm | 8.0mm10.0mm12mm14mm |
|---|---|---|
| Straumann Bone Level implants(K121131) | 4.1mm4.1mm4.1mm4.1mm | 8.0mm10.0mm12mm14mm |
| Straumann Bone Level implants(K121131) | 4.8mm4.8mm4.8mm4.8mm | 8.0mm10.0mm12mm14mm |
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)