(200 days)
The Biodenta Customized Abutment - Titanium is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. The Biodenta Customized Abutment - Titanium is compatible with the following dental implant systems:
| Implant Brand, Type | Implant Platform Name: Implant Diameter |
|---|---|
| Biodenta, Bone Level and Tapered | B1: 3.5 mm; B2: 4.1, 4.8, 6.0 mm |
| Nobel Biocare, Nobel Replace straight and tapered | NP: 3.5 mm; RP: 4.3 mm; WP: 5.0 mm; 6.0: 6.0 mm |
| Nobel Biocare, NobelActive | NP: 3.5 mm; RP: 4.3, 5.0 mm |
| Biomet 3i, Certain Internal | 3.4: 3.25, 4.0 mm; 4.1: 4.0, 5.0 mm; 5.0: 5.0, 6.0 mm; 6.0: 6.0 mm |
| Dentsply, Astra Tech OsseoSpeed | 3.5/4.0: 3.5, 4.0 mm; 4.5/5.0: 4.5, 5.0 mm |
| Straumann, Bone Level | NC: 3.3 mm; RC: 4.1, 4.8 mm |
| Zimmer, Screw Vent and Screw Vent Tapered | 3.5: 3.3, 3.7, 4.1 mm; 4.5: 4.7 mm; 5.7: 6.0 mm |
| Biohorizons, Internal straight and tapered | 3.5: 3.5, 3.8 mm; 4.5: 4.0, 4.6 mm; 5.7: 5.0, 6.0, 5.8 mm; |
| Osstem (Hiossen), GS and TS | Mini: 3.5 mm; Regular: 4.0, 4.5, 5.0 mm |
Biodenta Customized Abutment - Titanium is a one-piece custom abutment made of titanium. It utilizes an Abutment Screw for abutment retention.
The upper portion is designed by a dental technician using CAD software and manufactured at Biodenta milling centers. The final cement retained restoration is constructed in the lab according to the dentist's specifications.
The Abutment and the Abutment Screw are made of biocompatible Ti-6AI-4V ELI conforming to ISO 3852-3 and ASTM F136.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Biodenta Customized Abutment - Titanium:
Based on the provided document, the device in question is a dental abutment, and its acceptance criteria and supporting studies are focused on demonstrating substantial equivalence to predicate devices, primarily through mechanical and biocompatibility testing, rather than clinical performance metrics typically associated with AI-powered diagnostic tools.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with specific numerical targets for performance and reported device performance in the typical sense of a diagnostic or predictive device (e.g., sensitivity, specificity). Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to legally marketed predicate devices, and the "performance" is primarily shown through non-clinical testing results.
The critical acceptance criteria for this type of device revolve around:
- Mechanical Strength/Integrity: The device must demonstrate sufficient mechanical strength for its intended clinical application, particularly under fatigue loading.
- Biocompatibility: The materials used must be biocompatible.
- Fit and Compatibility: The customized abutment must fit well with the original manufacturer's implants as intended.
- Sterilization Effectiveness: The recommended sterilization method must be validated.
Here's a summary of the implicit acceptance criteria and the reported device performance:
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Mechanical Strength (Fatigue Resistance) | "Fatigue testing was conducted according to FDA Guidance... The results show that the Biodenta Customized Abutment - Titanium has sufficient mechanical strength for the intended clinical application." |
| Biocompatibility | "A biocompatibility assessment determined that biocompatibility testing was not necessary. Titanium has a long history of use in dental applications and Biodenta also has an established history of manufacturing titanium based dental devices." (Implied acceptance: material safety established by prior use/history) |
| Fit and Compatibility with Implants | "An engineering and compatibility analysis was carried out to ensure that the Biodenta Customized Abutment - Titanium fits well with the original manufacturer's implants..." |
| Sterilization Effectiveness | "The Sterilization Validation was carried out according to ISO 17665-1:2006. The recommended sterilization method is provided in the Information for Use." (Implied acceptance: sterilization is effective as validated.) |
| Overall Substantial Equivalence to Predicate Devices | "Biodenta Swiss AG demonstrated that... the Biodenta Customized Abutment - Titanium is substantially equivalent to the predicate devices in intended use, material composition, fundamental scientific technology, principles of operation, and basic design." |
| Custom Design Parameters (Max. Angulation, Diameter, Height) | * Maximal Abutment Angulation: 30° (Matches predicates) |
| * Abutment Diameter: 4.5 - 15 mm (Matches or extends range of predicates) | |
| * Abutment Height: 5.0 - 12.3 mm (Matches or extends range of predicates) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "test set" in the context of clinical trials with human subjects. The testing described is non-clinical:
- Fatigue Testing: "The worst-case scenario for the Biodenta Customized Abutment - Titanium and implant was tested." The sample size for fatigue testing (number of abutments/implants tested) is not specified.
- Engineering and Compatibility Analysis: This involved measuring "original implant manufacturer's implant analogs, abutments, and abutment screws." The number of samples measured is not specified.
- Sterilization Validation: Conducted according to ISO 17665-1:2006. Sample sizes for sterilization validation are not detailed.
The data provenance is from non-clinical laboratory testing conducted by Biodenta Swiss AG. The country of origin for the testing would presumably be Switzerland, where Biodenta Swiss AG is located. The nature of these tests is not "retrospective" or "prospective" as those terms apply to clinical studies; these are laboratory-based, controlled experiments.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This question is not applicable to the provided information. The device is a dental abutment, not a diagnostic imaging device or an AI algorithm requiring expert ground truth for a test set. The validation relies on engineering and material science principles, against established FDA guidance documents and international standards, rather than expert interpretation of clinical data in the manner of a diagnostic study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable for the same reason as point 3. There is no "test set" of clinical cases requiring expert adjudication.
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 question is not applicable. The device is a physical dental abutment, not an AI-assisted diagnostic tool. No MRMC study was conducted or is relevant to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. The device is a physical dental abutment, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device type is established by:
- Industry Standards and Regulatory Guidance: Adherence to FDA Guidance documents (e.g., "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments") and international standards (e.g., ISO 17665-1:2006 for sterilization).
- Material Properties: Established biocompatibility and mechanical properties of Ti-6AI-4V ELI as per ISO 3852-3 and ASTM F136.
- Engineering Measurements and Analysis: Ensuring precise fit and compatibility with specified implant systems based on direct measurements and engineering analysis.
8. The sample size for the training set
This question is not applicable. There is no "training set" in the context of an AI algorithm for this device. The design and manufacturing process for the customized abutment involves CAD software and milling centers, but this is an engineering process, not an AI training process.
9. How the ground truth for the training set was established
This question is not applicable as there is no training set for an AI algorithm. The design and manufacturing parameters for the abutment would be based on dental engineering principles, anatomical considerations, and compatibility specifications for various implant systems.
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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 features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 1, 2015
Biodenta Swiss AG Mr. David Eiler Regulatory Manager Tramstrasse 16 Berneck, St. Gallen 9442 SWITZERLAND
Re: K151295
Trade/Device Name: Biodenta Customized Abutment - Titanium Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: November 5, 2015 Received: November 23, 2015
Dear Mr. Eiler:
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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Image /page/2/Picture/1 description: The image shows the logo for Biodenta. The logo consists of the word "biodenta" in gray lowercase letters, with a registered trademark symbol to the right of the word. Above the word is a curved shape in two shades of green and gray.
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K151295
Device Name
Biodenta Customized Abutment - Titanium
Indications for Use (Describe)
The Biodenta Customized Abutment - Titanium is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. The Biodenta Customized Abutment - Titanium is compatible with the following dental implant systems:
| Implant Brand, Type | Implant Platform Name: Implant Diameter |
|---|---|
| Biodenta, Bone Level and Tapered | B1: 3.5 mm; B2: 4.1, 4.8, 6.0 mm |
| Nobel Biocare, Nobel Replace straight and tapered | NP: 3.5 mm; RP: 4.3 mm; WP: 5.0 mm; 6.0: 6.0 mm |
| Nobel Biocare, NobelActive | NP: 3.5 mm; RP: 4.3, 5.0 mm |
| Biomet 3i, Certain Internal | 3.4: 3.25, 4.0 mm; 4.1: 4.0, 5.0 mm; 5.0: 5.0, 6.0 mm; 6.0: 6.0 mm |
| Dentsply, Astra Tech OsseoSpeed | 3.5/4.0: 3.5, 4.0 mm; 4.5/5.0: 4.5, 5.0 mm |
| Straumann, Bone Level | NC: 3.3 mm; RC: 4.1, 4.8 mm |
| Zimmer, Screw Vent and Screw Vent Tapered | 3.5: 3.3, 3.7, 4.1 mm; 4.5: 4.7 mm; 5.7: 6.0 mm |
| Biohorizons, Internal straight and tapered | 3.5: 3.5, 3.8 mm; 4.5: 4.0, 4.6 mm; 5.7: 5.0, 6.0, 5.8 mm; |
| Osstem (Hiossen), GS and TS | Mini: 3.5 mm; Regular: 4.0, 4.5, 5.0 mm |
| 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.
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Image /page/3/Picture/1 description: The image shows the logo for Biodenta. The logo features the word "biodenta" in lowercase letters, with a stylized graphic above the text. The graphic is a curved shape in two shades of green and gray, positioned above the "bio" portion of the word. A small "R" in a circle is located to the right of the word.
K151295
5 510(k) Summary
| Owner's name: | Biodenta Swiss AG |
|---|---|
| Address: | Tramstrasse 169442 BerneckSwitzerland |
| Phone: | +41 71 747 11 11 |
| Fax number: | + 41 71 747 11 12 |
| Contact person: | Mr. David Eiler, Regulatory Manager |
| Date summary prepared: | November 27, 2015 |
| Trade / proprietary name: | Biodenta Customized Abutment - Titanium |
| Common name: | Endosseous dental implant abutment |
| Device classification name: | Endosseous Dental Implant Abutment |
| Product code: | NHA |
| Regulation number : | 21 CFR 872.3630 |
Legally marketed device to which equivalence is claimed (predicate device):
| 1. Company: | Biodenta Swiss Ag |
|---|---|
| Device name: | Biodenta Customized Abutment |
| 510(k) number: | K110778 (primary predicate) |
| 2. Company: | Prismark Dentalcraft, Inc |
| Device name: | Inclusive Titanium Abutments For Astra Tech OsseospeedImplants |
| 510(k) number: | K100993 |
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Image /page/4/Picture/1 description: The image shows the logo for Biodenta. The logo features the word "biodenta" in gray lowercase letters. Above the word is a curved design in light gray and light green. To the right of the word is a circled R symbol.
| 3. Company: | Prismark Dentalcraft, Inc |
|---|---|
| Device name: | Inclusive® Titanium Abutments compatible with:Straumann Bone Level, Nobel Biocare Branemark, andNobel Biocare NobelActive Implants |
| 510(k) number: | K142118 |
| 4. Company: | Prismark Dentalcraft, Inc |
| Device name: | Inclusive® Titanium Abutments, compatible with ZimmerScrew- Vent, Biomet 3i Certain, and Nobel BiocareNobelReplace Implants |
| 510(k) number: | K142115 |
| 5. Company: | Biodenta Swiss Ag |
| Device name: | Biodenta Dental Implant System - Multi-Use Abutment |
| 510(k) number: | K123491 |
Indications for Use:
The Biodenta Customized Abutment - Titanium is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
The Biodenta Customized Abutment - Titanium is compatible with the following dental implant systems:
110778
| Implant Brand, Type | Implant Platform Name: Implant Diameter |
|---|---|
| Biodenta, Bone Level and Tapered | B1: 3.5 mm; B2: 4.1, 4.8, 6.0 mm |
| Nobel Biocare, Nobel Replace straight and tapered | NP: 3.5 mm; RP: 4.3 mm;WP: 5.0 mm; 6.0: 6.0 mm |
| Nobel Biocare, NobelActive | NP: 3.5 mm; RP: 4.3, 5.0 mm |
| Biomet 3i, Certain Internal | 3.4: 3.25, 4.0 mm; 4.1: 4.0, 5.0 mm;5.0: 5.0, 6.0 mm; 6.0: 6.0 mm |
| Dentsply, Astra Tech OsseoSpeed | 3.5/4.0: 3.5, 4.0 mm; 4.5/5.0: 4.5, 5.0 mm |
| Straumann, Bone Level | NC: 3.3 mm; RC: 4.1, 4.8 mm |
| Zimmer, Screw Vent and Screw Vent Tapered | 3.5: 3.3, 3.7, 4.1 mm; 4.5: 4.7 mm; 5.7: 6.0 mm |
| Biohorizons, Internal straight and tapered | 3.5: 3.5, 3.8 mm; 4.5: 4.0, 4.6 mm;5.7: 5.0, 6.0, 5.8 mm; |
| Osstem (Hiossen), GS and TS | Mini: 3.5 mm; Regular: 4.0, 4.5, 5.0 mm |
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Image /page/5/Picture/1 description: The image shows the logo for Biodenta. The logo features the word "biodenta" in gray lowercase letters. Above the word is a curved design in light gray and light green. To the right of the word is a circled R symbol.
Device Description:
Biodenta Customized Abutment - Titanium is a one-piece custom abutment made of titanium. It utilizes an Abutment Screw for abutment retention.
The upper portion is designed by a dental technician using CAD software and manufactured at Biodenta milling centers. The final cement retained restoration is constructed in the lab according to the dentist's specifications.
The Abutment and the Abutment Screw are made of biocompatible Ti-6AI-4V ELI conforming to ISO 3852-3 and ASTM F136.
Non-clinical Testing Data:
Fatigue testing was conducted according to FDA Guidance: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments - Guidance for Industry and FDA Staff. The worst-case scenario for the Biodenta Customized Abutment - Titanium and implant was tested. The results show that the Biodenta Customized Abutment - Titanium has sufficient mechanical strength for the intended clinical application. A biocompatibility assessment determined that biocompatibility testing was not necessary. Titanium has a long history of use in dental applications and Biodenta also has an established history of manufacturing titanium based dental devices.
The engineering of the Biodenta Customized Abutment - Titanium was carried out by measuring the original implant manufacturer's implant analogs, abutments, and abutment screws. Compatible abutments and screws were developed based on the measurement results. An enqineering and compatibility analysis was carried out to ensure that the Biodenta Customized Abutment - Titanium fits well with the original manufacturer's implants (Nobel Biocare, Nobel Replace; Nobel Biocare, NobelActive; Biomet 3i, Certain Internal; Dentsply, Astra Tech OsseoSpeed; Straumann, Bone Level; Zimmer, Screw Vent and Screw Vent Tapered; Biohorizons, Internal straight and tapered; Osstem (Hiossen), GS/TS). Additionally fatigue testing according to FDA Guidance for Industry and Staff -Class II Special Controls Guidance Document: Root- form Endosseous Dental Implants and Endosseous Dental Implant Abutments was carried out to confirm the mechanical fatigue strength of the Biodenta Customized Abutment - Titanium on the original manufacturer's implant fixture.
The Sterilization Validation was carried out according to ISO 17665-1:2006. The recommended sterilization method is provided in the Information for Use.
Equivalence to marketed device:
While the indications for use statements between the subject and predicate device are not identical, the intended use is still the same. They are all abutments intended to be compatible with a specific subset of implants to support dental restorations. Biodenta Swiss AG demonstrated that, for the purposes of FDA's regulation of medical devices, the Biodenta Customized Abutment - Titanium is substantially equivalent to the predicate devices in intended use, material composition, fundamental scientific technology, principles of operation, and basic design.
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Image /page/6/Picture/1 description: The image shows the logo for "biodenta". The word "biodenta" is written in gray, with a registered trademark symbol to the right of the "a". Above the word is a curved design in gray and light green.
Summary Substantial Equivalence Comparison to predicate devices:
| Subject Device | Primary Predicate | Reference Predicates | |||||
|---|---|---|---|---|---|---|---|
| Company | Biodenta Swiss AG | Biodenta Swiss AG | PrismarkDentalcraft, Inc | PrismarkDentalcraft, Inc | PrismarkDentalcraft, Inc | Biodenta SwissAG | Pou Yu BiotechnologyCo., Ltd. |
| DeviceName | BiodentaCustomisedAbutment -Titanium | Biodenta CustomizedAbutment | Inclusive TitaniumAbutments For AstraTech OsseospeedImplants | Inclusive® TitaniumAbutments compatiblewith: Straumann BoneLevel, Nobel BiocareBranemark , and NobelBiocare NobelActiveImplants | Inclusive® TitaniumAbutments, compatiblewith Zimmer Screw-Vent, Biomet 3i Certain,and Nobel BiocareNobelReplace Implants | BiodentaDental ImplantSystem - Multi-Use Abutment | TDS Abutment forFriadent Xive |
| 510(k)Number | New device | K110778 | K100993 | K142118 | K142115 | K123491 | K103339 |
| Intendeduse | The BiodentaCustomizedAbutment isintended for usewith dentalimplants as asupport for singleor multiple toothprostheses in themaxilla or mandibleof a partially or fullyedentulous patient. | The Biodenta CustomizedAbutment is intended foruse with dental implants asa support for single or multiple tooth prostheses in themaxilla or mandible of a partially or fully edentulous patient. The Biodenta Customized Abutment is compatiblewith the following implantsystems: - Internal hex systems with flat-to-flat dimensions of 1.78mm or greater:Firadent: FRIALIT Implant,XiVA Implant: 3i: Certain Internal Connect Type; Astra:Osseospeed Implant, Osseospeed TX Implant; BioHorizons: Internal Implant System, Tapered Internal Implant System, Single-StageImplant System; Life core:Lifecore RENOVA InternalHex Implant System; Zimmer: Tapered Screw-Vent Implant System, Screw-Vent Implant System, AdVent Implant System. - Nobel BiocareReplace: NobelReplace Straight, NobelReplace TaperedReplace Select Tapered, Replace Select Straight; for theNP,RP,WPand6.0 implants.- External hex systems withflat-to-flat dimensions of 2.4mm or greater:Nobel Bioca | The InclusiveOTitanium Abutmentsfor AstraOsseoSpeed’MImplants arepremanufacturedprostheticcomponents directlyconnected toendlosseous dentalimplants and areintendedfor use as an aid inprostheticrehabilitation. Theyare compatible withthe Astra TechOsseoSpeed" 3.0,3.5, 4.0, 4.5, 5.0implants. | Inclusive® TitaniumAbutments arepremanufacturedprostheticcomponents directlyconnected toendosseous dentalimplants and areintended for use asan aid in prostheticrehabilitation.Inclusive® TitaniumAbutments arecompatible with:- Straumann: BoneLevel NC and RCimplant sizes- Nobel Biocare:Branemark RP sizeimplant- Nobel BiocareNobelActive NP andRP internalconnection implants | Inclusive® TitaniumAbutments arepremanufacturedprosthetic componentsdirectly connected toendosseous dentalimplants and areintended for use as anaid in prostheticrehabilitation.Inclusive® TitaniumAbutments arecompatible with:- Biomet: 3i Certaininternal hex implants in3.4, 4.1, 5.0, 6.0 mmsizes- Nobel Biocare:NobelReplace straightand tapered internalconnectionimplants in NP, RP, WP,6.0 mm sizes- Zimmer: Screw-Ventand Tapered Screw-Vent internal heximplants in 3.5,4.5, 5.7 mm sizes | BiodentaDental ImplantSystem MultiUse Abutmentsare intended forterminal orintermediateabutmentsupport forfixed orremovablecrown,bridgework andto retainoverdentures. | TDS Abutment for FriadentXive is intended for usewith dental implants as asupport for single ormultiple tooth prosthesesin the maxilla or mandibleof a partially or fullyedentulous patient.This device is compatiblewith the following implantsystems which have aninternal hex with flat-to-flatdimensions of 1.78mm orgreater: Firadent: FRIALITImplant, XiVA Implant; 3i:Internal Connect Type;Astra: OsseoispeedImplant, Osseospeed TXImplant; BioHorizons:Internal Implant System,Tapered Internal ImplantSystem, Single-StageImplant System, Laser-lok®&3.0 implant system;Lifecore: , Lifecore:RENOVATM Internal HexImplant System; Zimmer:Tapered Screw-VentImplant System, Screw-Vent Implant System,AdVent Implant System;Osstem: GS System;Nobel Biocare: ActiveImplant. |
| Subject Device | Primary Predicate | Reference Predicates | |||||
| Company | Biodenta Swiss AG | Biodenta Swiss AG | PrismarkDentalcraft, Inc | PrismarkDentalcraft, Inc | Biodenta SwissAG | Pou Yu BiotechnologyCo., Ltd. | |
| DeviceName | BiodentaCustomisedAbutment -Titanium | Biodenta CustomizedAbutment | Inclusive TitaniumAbutments For AstraTech OsseospeedImplants | Inclusive® TitaniumAbutments, compatiblewith: Straumann BoneLevel, Nobel BiocareBranemark , and NobelBiocare NobelActiveImplants | BiodentaDental ImplantSystem - Multi-Use Abutment | TDS Abutment forFriadent Xive | |
| 510(k)Number | New device | K110778 | K100993 | K142118 | K123491 | K103339 | |
| Compatible implanttypes | - Dentsply, AstraTechOsseoSpeed- Biomet 3i, CertainInternal- Zimmer, Screw Vent- Nobel Biocare,NobelReplace- Nobel Biocare,NobelActive- Straumann, BoneLevel- BioHorizons, Internal- Osstem, GS/TS- Biodenta, Bone Leveland Tapered | - Dentsply, AstraTechOsseoSpeed- Biomet 3i, CertainInternal- Zimmer, Screw Vent- Nobel Biocare,NobelReplace- Nobel Biocare,NobelActive- Straumann, BoneLevel | - Dentsply, AstraTechOsseoSpeed | - Nobel Biocare,NobelActive- Straumann, BoneLevel- Biomet: 3i Certaininternal- Zimmer: Screw-Vent- Nobel Biocare:NobelReplace | - Biodenta, BoneLevel and Tapered | - Dentsply, AstraTechOsseoSpeed- Biomet 3i, CertainInternal- Zimmer, Screw Vent- Nobel Biocare,NobelReplace- Nobel Biocare,NobelActive- Straumann, BoneLevel- BioHorizons, Internal- Osstem, GS/TS |
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Image /page/7/Picture/1 description: The image shows the logo for Biodenta. The logo consists of the word "biodenta" in gray, with a registered trademark symbol to the right of the word. Above the word is a curved design in gray and green.
Custom Design
| maximalAbutmentAngulation | 30° | 30° | 30° | 30° | 30° | 30° | 30° |
|---|---|---|---|---|---|---|---|
| AbutmentDiameter | 4.5 - 15 mm | 5 - 10 mm | max. 9.4 mm | max. 9.4 mm | max. 9.4 mm | 4.5 - 5.0 mm | 5 - 10 mm |
| AbutmentHeight | 5.0 - 12.3 mm | 3.0 - 7.5 mm | max 12.45 mm | max 12.45 mm | max 12.45 mm | 2.0 - 5.5 mm | 3.0 - 7.5 mm |
| Abutmentfixation | AbutmentScrew | AbutmentScrew | AbutmentScrew | AbutmentScrew | AbutmentScrew | AbutmentScrew | AbutmentScrew |
| CAD/CAMProcessing | Milled in Biodentamilling centerunder QSR control | Milled in Biodentamilling center underQSR control | Milled in manufact.milling center underQSR control | Milled in manufact.milling center underQSR control | Milled in manufact.milling center underQSR control | NA | Milled in manufact.milling center underQSR control |
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Image /page/8/Picture/1 description: The image shows the logo for "biodenta". The logo features the word "biodenta" in gray, with a stylized graphic above it. The graphic consists of two curved shapes, one in light gray and the other in light green, positioned to suggest movement or growth.
| Subject Device | Primary Predicate | Reference Predicates | ||||||
|---|---|---|---|---|---|---|---|---|
| Company | Biodenta Swiss AG | Biodenta Swiss AG | PrismarkDentalcraft, Inc | PrismarkDentalcraft, Inc | PrismarkDentalcraft, Inc | Biodenta SwissAG | Pou Yu BiotechnologyCo., Ltd. | |
| DeviceName | BiodentaCustomisedAbutment -Titanium | Biodenta CustomizedAbutment | Inclusive TitaniumAbutments For AstraTech OsseospeedImplants | Inclusive® TitaniumAbutments compatiblewith: Straumann BoneLevel, Nobel BiocareBranemark , and NobelBiocare NobelActiveImplants | Inclusive® TitaniumAbutments, compatiblewith Zimmer Screw-Vent, Biomet 3i Certain,and Nobel BiocareNobelReplace Implants | BiodentaDental ImplantSystem - Multi-Use Abutment | TDS Abutment forFriadent Xive | |
| 510(k)Number | New device | K110778 | K100993 | K142118 | K142115 | K123491 | K103339 | |
| Material | ||||||||
| Abutment +Screw | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI | |
| Sterile / Reuse | ||||||||
| Sterile | Delivered NonSterile | Delivered NonSterile | Delivered NonSterile | Delivered NonSterile | Delivered NonSterile | Delivered NonSterile | Delivered NonSterile | |
| Reusable | no | no | no | no | no | no | no |
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Image /page/9/Picture/1 description: The image shows the logo for Biodenta. The logo consists of the word "biodenta" in gray, with a registered trademark symbol to the right of the word. Above the word is a curved shape that is gray on top and light green on the bottom.
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§ 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.)