(101 days)
Inclusive® Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.
Inclusive® Titanium Abutments are compatible with:
- Biomet: 3i Certain internal hex implants in 3.4, 4.1, 5.0, 6.0 mm sizes -
- -Nobel Biocare: NobelReplace straight and tapered internal connection implants in NP, RP, WP, 6.0 mm sizes
- -Zimmer: Screw-Vent and Tapered Screw-Vent internal hex implants in 3.5, 4.5, 5.7 mm sizes
Inclusive Titanium Abutments are endosseous implant abutments which are placed into the dental implant to provide support for a prosthetic restoration. The abutment is placed over the implant shoulder and is fastened into the implant with a screw. Abutments are made of titanium grade 23 (Ti-6AL-4V ELI) and meet ASTM F-136 Standard.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Inclusive® Titanium Abutments.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for the device beyond demonstrating substantial equivalence to predicate devices. However, the non-clinical testing performed implicitly defines performance metrics that align with the safety and effectiveness requirements of the predicate devices.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Reliability (e.g., structural integrity, consistency) | Reliability Calculation performed. The testing "established that the predicate device is as safe, as effective, and performs as well as the predicate device(s)." (implies meeting established reliability standards) |
| Fatigue Life (resistance to repeated stress) | Fatigue Testing of finished assembled implant/abutment systems performed. The testing "established that the predicate device is as safe, as effective, and performs as well as the predicate device(s)." (implies meeting or exceeding predicate device's fatigue performance) |
| Static Load Failure (resistance to maximum applied force) | Static Load Failure Testing of finished assembled implant/abutment systems performed. The testing "established that the predicate device is as safe, as effective, and performs as well as the predicate device(s)." (implies meeting or exceeding predicate device's static load failure threshold) |
| Implant to Abutment Compatibility (proper fit and connection) | Demonstrated "implant to abutment compatibility" through testing. |
| Sterilization Efficacy | Sterilization validation information and a recommended sterilization method based on ANSI/AAMI ST79 and ISO 17665-1 is provided. (Implies the device can be effectively sterilized according to recognized standards). |
| Equivalence in Intended Use | Stated as "substantially equivalent ... in intended use" to predicate devices. The "Indications for Use" statement is similar to predicate devices, though wording varies. |
| Equivalence in Materials | Stated as "substantially equivalent ... in materials." Made of titanium grade 23 (Ti-6AL-4V ELI) meeting ASTM F-136 Standard, same as predicate devices. |
| Equivalence in Design | Stated as "substantially equivalent ... in design" to predicate devices, with detailed comparison tables showing high similarity in dimensions, connection types, design/construction (machined), anatomical site, implant seat, and screw seat. Note: Abutment angle range has increased. |
| Equivalence in Performance | Stated as "substantially equivalent ... in performance" to predicate devices, supported by the non-clinical testing results. |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "Non-clinical test data was used to evaluate the device's safety and effectiveness." However, it does not specify the sample sizes used for the Reliability Calculation, Fatigue Testing, or Static Load Failure Testing.
The data provenance is non-clinical testing, performed by the manufacturer, Prismatik Dentalcraft, Inc. It's an engineering and materials testing study, not a human clinical study, so concepts like "country of origin of data" or "retrospective/prospective" in the typical sense for clinical trials are not directly applicable. These would be laboratory-generated data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable in the context of this device. The "ground truth" for non-clinical engineering tests (like fatigue or static load failure) is determined by established engineering standards and physical failure points, not by expert consensus on interpretations. The "ground truth" for material composition is based on material specifications (ASTM F-136 Standard).
4. Adjudication Method for the Test Set
This is not applicable for the type of non-clinical testing described. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or image interpretation studies where multiple human readers assess data and discrepancies need to be resolved. The non-clinical tests involve objective measurements and failure points.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical data (e.g., images) with and without AI assistance. The device in question is a dental implant abutment, which is a physical component, not a diagnostic AI tool.
6. Standalone (Algorithm only without human-in-the-loop performance) Study
Yes, in spirit, a standalone performance study was done. The device itself is a physical component (an abutment), and the performance testing (Reliability, Fatigue, Static Load Failure) evaluates the device's intrinsic mechanical properties and compatibility with implants, independent of human interaction during its function. The "human in the loop" for an abutment is a dentist placing it and a patient using it, but the tests conducted are assessing the device's inherent physical performance, which is "standalone" in that context. There's no "algorithm" here, but the physical device's performance was evaluated independently.
7. Type of Ground Truth Used
The "ground truth" for the non-clinical tests was based on:
- Engineering Standards: Referenced FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments," and implicitly, the performance characteristics of the legally marketed predicate devices.
- Material Specifications: ASTM F-136 Standard for titanium grade 23 (Ti-6AL-4V ELI).
- Objective Physical Failure Points: Mechanical failure under controlled loading conditions.
- Established Sterilization Standards: ANSI/AAMI ST79 and ISO 17665-1.
8. Sample Size for the Training Set
This is not applicable. The device is a physical medical device, not a machine learning or AI algorithm that requires a "training set" of data. The manufacturing process and design are based on established engineering principles and materials science, not statistical learning from data.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no "training set" for this physical device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 13,2014
Prismatik Dentalcraft, INC Brandon Shepard Regulatory Affairs & Ouality Assurance Specialist 2212 Dupont Dr. Suite P Irvine, California 92612
Re: K142115
Trade/Device Name: Inclusive® Titanium Abutments, compatible with Zimmer Screw-Vent, Biomet 3i Certain, and Nobel Biocare NobelReplace Implants Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous dental implant abutment Regulatory Class: II Product Code: NHA Dated: October 10, 2014 Received: October 14, 2014
Dear Mr. Shepard:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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,
Susan Runno DDS, mA
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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Indications for Use
510(k) Number: K142115
Device Name: Inclusive® Titanium Abutments, compatible with Zimmer Screw-Vent, Biomet 3i Certain, and Nobel Biocare NobelReplace Implants
Indications for Use:
Inclusive® Titanium Abutments are premanufactured prosthetic components directly
connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.
Inclusive® Titanium Abutments are compatible with:
-
Biomet: 3i Certain internal hex implants in 3.4, 4.1, 5.0, 6.0 mm sizes -Nobel Biocare: NobelReplace straight and tapered internal connection implants in NP, RP, WP, 6.0 mm sizes
-
Zimmer: Screw-Vent and Tapered Screw-Vent internal hex implants in 3.5. 4.5. 5.7 mm sizes
Prescription Use 1 (Part 21 CFR 801 Subpart D)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Image /page/3/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. On the left is a triangle with a gradient of colors, including pink, blue, and yellow. To the right of the triangle is the text "PRISMATIK DENTALCRAFT, INC." in a sans-serif font.
| 005 | 51 |
|---|---|
| ----- | ---- |
10(k) Summary
[As Required by 21 CFR 807.92]
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements 21 CFR 807.92.
SUBMITTER INFORMATION A.
B.
| Company Name: | PRISMATIK DENTALCRAFT, INC. |
|---|---|
| Company Address: | 2212 Dupont Dr., Suite PIrvine, CA 92612 |
| Company Phone / Fax: | (949) 225-1269 / (978) 313-0850 |
| Contact Person: | Primary Contact:• Brandon Shepard, (949) 225-1243Secondary Contact:• Marilyn Pourazar, (949) 225-1269 |
| Date Summary Prepared: | August 1, 2014 |
DEVICE IDENTIFICATION
| Trade/Proprietary Name: | Inclusive ® Titanium Abutmentscompatible with: Zimmer Screw-Vent, Biomet 3iCertain, and Nobel Biocare NobelReplace Implants |
|---|---|
| Common Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | 872.3630 |
| Product Code: | NHA |
| Device Class: | 2 |
| Review Panel: | Dental |
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Image /page/4/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. On the left is a triangle with a rainbow gradient. To the right of the triangle is the company name, "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line. The text is in a blue sans-serif font.
C. IDENTIFICATION OF PREDICATE DEVICE
Trade/Proprietary Name:
- · Inclusive 110 Abutment for Zimmer, 3i and Nobel Biocare Implants (K073217)
- · NobelProcera Ti Abutment (K091756)
- · BIOMET 3i Dental Abutments and Restorative Components (K072642)
- · Zimmer Ti Prepable Abutment (K092403).
D. DEVICE DESCRIPTION
Inclusive Titanium Abutments are endosseous implant abutments which are placed into the dental implant to provide support for a prosthetic restoration. The abutment is placed over the implant shoulder and is fastened into the implant with a screw. Abutments are made of titanium grade 23 (Ti-6AL-4V ELI) and meet ASTM F-136 Standard.
E. INDICATIONS FOR USE
Inclusive® Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.
Inclusive® Titanium Abutments are compatible with:
- Biomet: 3i Certain internal hex implants in 3.4, 4.1, 5.0, 6.0 mm sizes -
- -Nobel Biocare: NobelReplace straight and tapered internal connection implants in NP, RP, WP, 6.0 mm sizes
- -Zimmer: Screw-Vent and Tapered Screw-Vent internal hex implants in 3.5, 4.5, 5.7 mm sizes
NON-CLINICAL TESTING F.
Non-clinical test data was used to evaluate the device's safety and effectiveness, and determine substantial equivalence with predicate devices.
Non-clinical testing was performed in accordance with FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments" and it consisted of Reliability Calculation, Fatigue Testing and Static Load Failure Testing of finished assembled implant/abutment systems.
In addition, sterilization validation information and a recommended sterilization method based on ANSI/AAMI ST79 and ISO 17665-1 is provided in the Information for Use.
The testing performed demonstrated implant to abutment compatibility and established that the predicate device is as safe, as effective, and performs as well as the predicate device(s).
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Image /page/5/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a colorful triangle on the left and the company name on the right. The triangle is divided into sections of different colors, including pink, purple, blue, green, and yellow. The company name is written in blue, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line.
SUBSTANTIAL EQUIVALENCE G.
Inclusive® Titanium Abutments, compatible with Zimmer Screw-Vent, Biomet 3i Certain and Nobel Biocare NobelReplace Implants are substantially equivalent to the Inclusive™ Abutment for Zimmer, 3i and Nobel Biocare Implants (K073217) and the OEM predicates, (K091756, K072642, and K092403), identified in Section C above. They are substantially equivalent in intended use, materials, design and performance.
(See Comparison Tables below).
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Image /page/6/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. The logo consists of a colorful triangle on the left and the company name on the right. The triangle is divided into sections with different colors, including pink, purple, blue, and yellow. The company name is written in a sans-serif font, with "PRISMATIK" on the first line and "DENTALCRAFT, INC." on the second line.
| Predicate Device (1) | Predicate Device (2) | Proposed Device | ||
|---|---|---|---|---|
| Ti Prepable Abutment(K092403) | Inclusive Abutment forZimmer, 3i, and Nobel BiocareImplants (K073217) | Inclusive TitaniumAbutments compatiblewith: NobelReplaceImplants | Similarities andDifferences | |
| Manufacturer | Zimmer Dental | Prismatik Dentalcraft, Inc. | Prismatik Dentalcraft, Inc. | N/A |
| Dimensions ofAbutment | Hex Dimensions:2.4mm Across Flats3.0mm Across Flats | Cylindrical Diameter: 9.4mmHex Dimensions:2.4mm Across Flats3.0mm Across Flats | Cylindrical Diameter: 9.4mmHex Dimensions:2.4mm Across Flats3.0mm Across Flats | Same |
| Abutment ScrewManufacturer | OEM (Zimmer) | OEM (Zimmer) | Inclusive (Prismatik) | Equivalent screwfrom differentmanufacturer |
| Dimensions ofAbutment Screw | Length 8.2mm; 1-72 UNF-2AThread | Length 8.2mm; 1-72 UNF-2AThread | Length 8.2mm; 1-72 UNF-2AThread | Same |
| Indications for Use | The Ti Prepable Abutments aredesigned for use as a terminal orintermediate abutment for cementretained prosthesis. It allows forpreparation for the crown to beattached. It can be used for asingle or multiple-unit restoration.The abutment is intended to beprepared and placed with patientspecific margins. | The Inclusive Abutment isintended to be used inconjunction with endosseousimplants in the maxillary and/ormandibular arch to providesupport for crowns, bridges oroverdenture prostheses. Theprosthesis can be cementretained to the abutment. Theabutment screw is intended tosecure the abutment to theendosseous implant. | Inclusive TitaniumAbutments arepremanufactured prostheticcomponents directlyconnected to endosseousdental implants and areintended for use as an aid inprosthetic rehabilitation. | Same IntendedUse. Differentwording in theIndications forUse |
| PlatformCompatibility | Zimmer Dental Screw-Vent3.5, 4.5, 5.7mm | Zimmer Dental Screw-Vent3.5, 4.5, 5.7mm | Zimmer Dental Screw-Vent3.5, 4.5, 5.7mm | Same |
| Connection | Internal Hex | Internal Hex | Internal Hex | Same |
| Design/Construction | Machined | Machined | Machined | Same |
| Anatomical Site | Oral Cavity | Oral Cavity | Oral Cavity | Same |
| Abutment Angle | 0° | 0°-20° | 0°-30° | Similar; increasedangulation range |
| Implant Seat | Flat | Flat | Flat | Same |
| Screw Seat | Flat | Flat | Flat | Same |
| Material | Titanium Alloy | Titanium Alloy | Titanium Alloy | Same |
| Predicate Device (1) | Predicate Device (2) | Proposed Device | ||
| Biomet 3i Dental Abutments &Restorative Components (K072642) | Inclusive Abutment forZimmer, 3i, and Nobel BiocareImplants (K073217) | Inclusive TitaniumAbutments compatible with:Biomet 3i Certain Implants | Similarities andDifferences | |
| Manufacturer | Biomet | Prismatik Dentalcraft, Inc. | Prismatik Dentalcraft, Inc. | N/A |
| Dimensions ofAbutment | Hex Dimensions:2.2mm Across Flats2.7mm Across Flats | Cylindrical Diameter: 9.4mmHex Dimensions:2.2mm Across Flats2.7mm Across Flats | Cylindrical Diameter: 9.4mmHex Dimensions:2.2mm Across Flats2.7mm Across Flats | Same |
| Abutment ScrewManufacturer | OEM (Biomet 3i) | OEM (Biomet 3i) | Inclusive (Prismatik) | Equivalent screwfrom differentmanufacturer |
| Dimensions ofAbutment Screw | Length: 8.4mm; M1.6 Thread | Length: 8.4mm; M1.6 Thread | Length: 8.4mm; M1.6 Thread | Same |
| Indications for Use | Biomet 3i Dental Abutments areintended for use as accessories toendosseous dental implant to supporta prosthetic device in a partially orcompletely edentulous patient. Adental abutment is intended for use tosupport single and multiple toothprosthesis, in the mandible or maxilla.The prosthesis can be screw retainedor cement retained. | The Inclusive Abutment isintended to be used inconjunction with endosseousimplants in the maxillary and/ormandibular arch to providesupport for crowns, bridges oroverdenture prostheses. Theprosthesis can be cementretained to the abutment. Theabutment screw is intended tosecure the abutment to theendosseous implant. | Inclusive Titanium Abutmentsare premanufactured prostheticcomponents directly connectedto endosseous dental implantsand are intended for use as anaid in prosthetic rehabilitation. | Same IntendedUse. DifferentIndications forUse statement. |
| PlatformCompatibility | Biomet 3i Certain3.4, 4.1, 5.0, 6.0mm | Biomet 3i Certain3.4, 4.1, 5.0, 6.0mm | Biomet 3i Certain3.4, 4.1, 5.0, 6.0mm | Same |
| Connection | Internal Hex | Internal Hex | Internal Hex | Same |
| Design/Construction | Machined | Machined | Machined | Same |
| Anatomical Site | Oral Cavity | Oral Cavity | Oral Cavity | Same |
| Abutment Angle | 0°-15° | 0°-20° | 0°-30° | Similar; increasedangulation range |
| Implant Seat | Flat | Flat | Flat | Same |
| Screw Seat | Flat | Flat | Flat | Same |
| Material | Titanium Alloy | Titanium Alloy | Titanium Alloy | Same |
| Predicate Device (1) | Predicate Device (2) | Proposed Device | ||
| NobelProcera Ti Abutment(K091756) | Inclusive Abutment forZimmer, 3i, and NobelBiocare Implants(K073217) | Inclusive TitaniumAbutments compatiblewith: Nobel BiocareNobelReplace Implants | Similarities andDifferences | |
| Manufacturer | Nobel Biocare | Prismatik Dentalcraft, Inc. | Prismatik Dentalcraft, Inc. | N/A |
| Dimensions ofAbutment | Connection Length: 2.9mm | Cylindrical Diameter: 9.4mmConnection Length: 2.9mm | Cylindrical Diameter: 9.4mmConnection Length: 2.9mm | Same |
| Abutment ScrewManufacturer | OEM (Nobel Biocare) | OEM (Nobel Biocare) | Inclusive (Prismatik) | Equivalent screw fromdifferent manufacturer |
| Dimensions ofAbutment Screw | Length 8.3mm; M1.8 Thread | Length 8.3mm; M1.8 Thread | Length 8.3mm; M1.8 Thread | Same |
| Indications for Use | The NobelProcera TiAbutments arepremanufactured prostheticcomponents directly connectedto endosseous dental implantsand are intended for use as anaid in prosthetic rehabilitation. | The Inclusive Abutment isintended to be used inconjunction with endosseousimplants in the maxillaryand/or mandibular arch toprovide support for crowns,bridges or overdentureprostheses. The prosthesis canbe cement retained to theabutment. The abutmentscrew is intended to secure theabutment to the endosseousimplant. | Inclusive TitaniumAbutments arepremanufactured prostheticcomponents directlyconnected to endosseousdental implants and areintended for use as an aid inprosthetic rehabilitation. | Same Intended Use.Different Indicationsfor Use statement. |
| PlatformCompatibility | Nobel Biocare NobelReplaceNP, RP, WP, 6.0 | Nobel Biocare NobelReplaceNP, RP, WP, 6.0 | Nobel Biocare NobelReplaceNP, RP, WP, 6.0 | Same |
| Connection | Internal Trilobe | Internal Trilobe | Internal Trilobe | Same |
| Design/Construction | Machined | Machined | Machined | Same |
| Anatomical Site | Oral Cavity | Oral Cavity | Oral Cavity | Same |
| Abutment Angle | 0°-30° | 0°-20° | 0°-30° | Similar; increasedangulation range |
| Implant Seat | Flat | Flat | Flat | Same |
| Screw Seat | Flat | Flat | Flat | Same |
| Material | Titanium Alloy | Titanium Alloy | Titanium Alloy | Same |
Comparison of Predicate and Proposed Devices: Zimmer Screw-Vent Platform
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Image /page/7/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. On the left is a triangle with different colors. The text "PRISMATIK DENTALCRAFT, INC." is on the right in a blue sans-serif font.
Comparison of Predicate and Proposed Devices: Biomet 3i Certain Platform
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Image /page/8/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a colorful triangular prism on the left and the company name on the right. The prism is made up of various colors, including pink, purple, blue, and green. The company name is written in a sans-serif font.
Comparison of Predicate and Proposed Devices: Nobel Biocare NobelReplace Platform
§ 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.)