(167 days)
The Allied Biocompat abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prostheses in the mandible or maxilla. The prosthesis can be cemented or screw retained to the abutment screw is intended to secure the Allied Dental Solutions abutment to the endosseous implant.
Allied Biocompat Abutments are compatible with the following
Implant Manufacturer: Nobel Biocare
Implant Line: Replace Select Straight and Select Straight One Stage, Replace Select Tapered one Stage
Implant Diameters: 3.5 (NP), 4.0 (RP), 5.0 (WP) and 6.0
Allied Biocompat patient-specific abutments are made from Ti-6Al-4V ELI which meets ASTM F136. Two abutment screw designs are included because the standard one does not fit the narrowest platform. The abutment is placed over the shoulder of the implant and fastened with the appropriate abutment screw. The patient-specific abutments designs share the same internal tri-lobe prosthetic interface but there are different implant platform diameters so there are 4 different diameters of abutment. The maximum angulation which can be ordered is 25°.
Allied Biocompat NB internal tri-lobe 3.5mm Allied Biocompat NB internal tri-lobe 4.0mm Allied Biocompat NB internal tri-lobe 5.0mm Allied Biocompat NB internal tri-lobe 6.0mm
These are patient-specific CAD/CAM abutments designed and fabricated under the manufacturing control of Allied Dental Solutions.
The provided text describes a 510(k) premarket notification for the "Allied Biocompat Abutment for Nobel Replace Interface." This document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than outlining a study with specific acceptance criteria and detailed performance metrics for a novel medical device like an AI algorithm.
Therefore, many of the requested details about acceptance criteria, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not applicable to this document. This submission is for a medical device (dental abutment) and relies on material and fatigue testing, not AI performance evaluation.
However, I can extract the available information related to the device's performance demonstration:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the traditional sense of numerical targets for an AI algorithm's performance (e.g., sensitivity, specificity). Instead, it demonstrates compliance with a standard and equivalence to a predicate device.
| Test/Characteristic | Acceptance Criteria (Implied by Predicate & Standard) | Reported Device Performance (Allied Biocompat Abutments) |
|---|---|---|
| Fatigue Testing | Pass ISO 14801 (as completed by predicate) | Passed testing according to ISO 14801 |
| Fit Analysis | Abutments will fit the listed interfaces | Conducted (reverse engineering compatibility) |
| Sterilization | SAL of ≤ 10⁶ validated, Dry time validated | Validated by biological indicators overkill method |
| Biocompatibility | Cytotoxicity testing according to ISO 10993-5 | Demonstrated by testing cytotoxicity |
| Material | Meet ASTM F136 (as used by predicate) | Ti-6Al-4V ELI which meets ASTM F136 |
| Indications for Use | Substantially equivalent to predicate | Substantially equivalent (with minor stated exceptions) |
| Diameters | Compatible with predicate's diameters | 3.5, 4.3, 5, 6 (compatible with predicate) |
| Interface type/shape | NB internal tri-lobe (same as predicate) | NB internal tri-lobe (same as predicate) |
| Maximum Angulation | Patient-specific of no more than 30° (predicate) | Patient-specific of no more than 25° (smaller than predicate, but deemed acceptable) |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The testing described (e.g., fatigue testing) would involve a sample of physical devices, but the specific number tested is not mentioned. The data provenance is laboratory testing rather than clinical data.
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)
Not applicable. This is a physical device, and "ground truth" refers to engineering specifications and material properties, not interpretations by medical experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a physical device.
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
Not applicable. This is a physical device and not an AI algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device and not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance relies on:
- Established engineering standards: ISO 14801 for fatigue testing, ASTM F136 for material specifications, ISO 10993-5 for biocompatibility.
- Predicate device characteristics: Demonstrating that the new device performs comparably to a legally marketed predicate device (Atlantis Abutments K053654 and K981858, among others) in terms of materials, design, and fatigue performance.
- Validated laboratory methods: For sterilization and fit analysis.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
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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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure in profile, with three overlapping heads or faces.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 14, 2016
Allied Dental Solutions Mr. Peter Zhou President 1170 Centre Drive #I City of Industry, California 91789
Re: K152845
Trade/Device Name: Allied Biocompat Abutment for Nobel Replace Interface Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: February 2, 2016 Received: February 9, 2016
Dear Mr. Zhou:
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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Indications for Use
510(k) Number (if known) K152845
Device Name
Allied Biocompat Abutment for Nobel Replace Interface
Indications for Use (Describe)
The Allied Biocompat abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prostheses in the mandible or maxilla. The prosthesis can be cemented or screw retained to the abutment screw is intended to secure the Allied Dental Solutions abutment to the endosseous implant.
Allied Biocompat Abutments are compatible with the following
Implant Manufacturer: Nobel Biocare
Implant Line: Replace Select Straight and Select Straight One Stage, Replace Select Tapered one Stage
Implant Diameters: 3.5 (NP), 4.0 (RP), 5.0 (WP) and 6.0
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510k Summary March 11, 2016 Allied Biocompat Abutments for Nobel Replace Interface
Name and address:
Allied Dental Solutions Peter Zhou 1170 Centre Drive #I City of Industry, California 91789 (909) 598-8036 www.allieddentalsolutions.com
Name of device: Allied Biocompat Abutments for Nobel Replace Interface Classification Name: Endosseous dental implant abutment CFR: 21 CFR 872.3630 Product Code: NHA
Device Description: Allied Biocompat patient-specific abutments are made from Ti-6Al-4V ELI which meets ASTM F136. Two abutment screw designs are included because the standard one does not fit the narrowest platform. The abutment is placed over the shoulder of the implant and fastened with the appropriate abutment screw. The patient-specific abutments designs share the same internal tri-lobe prosthetic interface but there are different implant platform diameters so there are 4 different diameters of abutment. The maximum angulation which can be ordered is 25°.
Allied Biocompat NB internal tri-lobe 3.5mm Allied Biocompat NB internal tri-lobe 4.0mm Allied Biocompat NB internal tri-lobe 5.0mm Allied Biocompat NB internal tri-lobe 6.0mm
These are patient-specific CAD/CAM abutments designed and fabricated under the manufacturing control of Allied Dental Solutions.
Indications for Use: The Allied Biocompat abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prostheses in the maxilla. The prosthesis can be cemented or screw retained to the abutment screw is intended to secure the Allied Dental Solutions abutment to the endosseous implant.
Allied Biocompat Abutments are compatible with the following
Implant Manufacturer: Nobel Biocare
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Implant Line: Replace Select Straight One Stage, Replace Select Tapered and Select Tapered One Stage
Implant Diameters: 3.5 (NP), 4.0 (RP), 5.0 (WP) and 6.0
Testing Summary: Fit analysis (reverse engineering compatibility) to determine the abutments will fit the interfaces listed above was conducted. Dynamic fatigue testing according to ISO 14801 was conducted to determine the abutments are strong enough for their intended use. The steam sterilization instructions were validated by the biological indicators over kill method. An SAL of ≤ 10° was validated. Dry time was validated using full cycle parameters. Materials used in the product meet ASTM F136 and the biocompatibility was demonstrated by testing the cytotoxicity according to ISO 10993-5.
Predicate Device: Primary Predicate Atlantis Abutments K053654 and Reference Predicates Atlantis Abutments K981858, Replace TiUnite Endosseous Implant K023113, and Replace HA Coated Implant K020646
Substantial Equivalence:
Allied Biocompat abutments are substantially equivalent to Atlantis Abutments in indications for use (except for the slightly less max angulation, early loading, and highly angled abutment statements that do not change the intended use and are addressed in the labeling), materials, design, and fatigue performance. Fatigue testing according to ISO 14801 was completed for Allied Biocompat abutments and was successful. Both Allied Biocompat and Atlantis successfully completed ISO 14801 fatigue tests.
| Company | Allied Biocompat Abutments | Atlantis Abutments K053654and K981858 |
|---|---|---|
| Indications for Use | The Allied Biocompat abutmentis intended for use with anendosseous implant to supporta prosthetic device in a partiallyor completely edentulouspatient. It is intended for use tosupport single and multipletooth prostheses in themandible or maxilla. Theprosthesis can be cemented orscrew retained to theabutment. The abutment screwis intended to secure the AlliedDental Solutions abutment tothe endosseous implant.Allied Biocompat Abutments arecompatible with the followingImplant Manufacturer: NobelBiocareImplant Line: Replace Select | The Atlantis abutment isintended for use as an accessoryto an endosseous implant tosupport a prosthetic device in apartially or completelyedentulous patient. It isintended for use to supportsingle and multiple toothprostheses in the mandible ormaxilla. The prosthesis can becement retained to theabutment. The abutment screwis intended to secure theabutment to the endosseousimplant.This device is compatible withNobel Biocare Replace SelectStraight, Replace Select StraightOne Stage, Replace SelectTapered and Replace Select |
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| Straight and Select Straight One Stage, Replace Select Tapered and Select Tapered One Stage Implant Diameters: 3.5 (NP), 4.0 (RP), 5.0 (WP) and 6.0 | Tapered One Stage. | |
|---|---|---|
| This device may be used in an early loading situation, but is dependent on the specific implant system and protocol used by the dental professional. Highly angled abutments (i.e.30 degrees) on implants with diameters less than 4mm are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant. | ||
| Diameters | 3.5, 4.3, 5, 6 | 3.5, 4.3, 5, 6 |
| Material | Ti-6AL-4V ELI | Ti-6AL-4V ELI |
| Fatigue testing | Passed testing according to ISO 14801 | Passed testing according to ISO 14801 |
| Type of abutment and maximum angulation | Patient-specific of no more than 25° | Patient-specific of no more than 30° |
| Interface type/shape | NB internal tri-lobe | NB internal tri-lobe |
The reference predicates K020646 and K023113 demonstrate substantial equivalence for the implants listed as compatible with the Allied Biocompat abutment.
Conclusion:
Allied Biocompat abutments are substantially equivalent to Atlantis Abutments. They both have the same indications for use (with the exceptions mentioned above), are of the same material, fit the same implants (thus have identical interfaces), and both passed ISO 14801 fatigue testing successfully. Allied Biocompat abutments have a smaller maximum angulation because the software controlling the design limits for milling made designs with larger angulation than 25° undesirable due to other parameters like diameter, height, etc. Restricting the angulation does not affect the substantial equivalence.
The Allied Biocompat abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prostheses in the mandible or maxilla. The prosthesis can be cemented or screw retained to the abutment. The abutment screw is intended to secure the Allied Dental Solutions abutment to the endosseous implant.
§ 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.)