AccuFit™ Abutments and screws are intended to attach to an endosseous dental implant and provide support and retention for a single tooth and multiple teeth restoration in the mandible or maxilla.

AccuFit™ Screws are intended for securing a abutment onto an endosseous dental implant.

The AccuFit" Abutment System is compatible with the commercial implant manufacturer's (Table A) bone-level implant bodies and has mating diameters, lead-in bevels, internal/external hex sizes, and internal threads. Abutments and screws are designed to be compatible with each of the following implant systems and sizes:

Table A. Compatible Commercial Implant Manufacturers

Implant Company	Implant System	Implant Platform Diameter
Zimmer Dental	Tapered Screw-vent	3.5, 4.5, 5.7 mm
Nobel-Biocare	NobelReplace Select	3.5, 4.3, 5.0 mm
Biomet 3i	Osseotite Certain	3.4, 4.1, 5.0 mm
Lifecore Biomedical	Renova (internal hex)	3.5, 4.5 mm
	Restore (external hex)	3.3, 4.1, 5.0 mm

Device Description

The AccuFit" Dental Abutments and Screws are designed for use with commercially available dental implant systems. The abutments will seat directly on implants and are secured by screws to become sub-structure of prosthesis. These abutments are offered in a straight body with a straight or scalloped prosthetic margin and are made of Titanium alloy Ti6AlV4.

A list of dental implant systems, which the AccuFit™ family of products is compatible with, is shown in tables within this document. The abutments and screws of the compatible systems are listed as the predicates for this filing.

The Accurit™ Abutment System is compatible with the commercial implant manufacturer's (Table A) bone-level implant bodies and has mating diameters, lead-in bevels, internal/external hex sizes, and internal threads. Abutments and screws are designed to be compatible with each of the following implant systems and sizes:

Table A. Compatible Commercial Implant Manufacturers

Implant Company	Implant System	Implant Platform Diameter
Zimmer Dental	Tapered Screw-vent	3.5, 4.5, 5.7 mm
Nobel-Biocare	NobelReplace Select	3.5, 4.3, 5.0 mm
Biomet 3i	Osseotite Certain	3.4, 4.1, 5.0 mm
Lifecore	Renova (internal hex)	3.5, 4.5 mm
Biomedical	Restore (external hex)	3.3, 4.1, 5.0 mm

AI/ML Overview

This document is a 510(k) Premarket Notification for the AccuFit™ Dental Implant Abutments and Screws. It describes the device's characteristics and compares it to predicate devices to establish substantial equivalence.

Here's an analysis of the provided text in relation to acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The document describes the acceptance criteria implicitly through the comparison to predicate devices and the process of ensuring compatibility. The primary acceptance criterion is substantial equivalence to existing legally marketed dental implant abutments and screws.

The "reported device performance" is not quantified in terms of specific performance metrics (like wear resistance, fracture strength in controlled studies, etc.) in this submission. Instead, performance is demonstrated by adhering to material standards and ensuring a precision fit with compatible implant systems.

Acceptance Criterion (Implied)	Reported Device Performance
Material Composition	Made of Titanium alloy Ti6Al4V (ASTM F136-08e1 compliant), identical to predicate devices.
Overall Design & Technological Characteristics	Similar to predicate devices.
Intended Use	Identical to predicate devices: attach to an endosseous dental implant for support and retention of single/multiple tooth restoration; securing an abutment onto an endosseous dental implant.
Compatibility/Precision Fit	Precision fit achieved through measurements with high-precision optical equipment and cross-assembly with commercially acquired samples. Screws are tightened to implant manufacturer specified torque. Berkeley Implant monitors compatible implants for modifications.

Study Information

The document describes a bench study/testing rather than a clinical trial or a study involving human subjects or AI performance.

Sample size used for the test set and the data provenance:
- Test Set Description: The "test set" consists of commercially available implant components from various manufacturers (Zimmer Dental, Nobel-Biocare, Biomet 3i, Lifecore Biomedical) that the AccuFit™ system is designed to be compatible with.
- Sample Size: The document does not specify a numerical sample size (e.g., how many units of each compatible implant system were purchased for testing). It ambiguously states, "The commercially available implant components are purchased as samples."
- Data Provenance: The data provenance is described as "commercially acquired samples" from various implant companies. This implies the data is retrospective in the sense that the compatible implants are pre-existing, but the testing performed by Berkeley Implant would be prospective for their device. The country of origin of these commercial implants is not specified, but they are recognized manufacturers in the dental implant market.
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 submission does not involve medical image analysis or interpretation, and therefore, there are no "experts" in the sense of clinical specialists establishing a "ground truth" for a diagnostic task. The ground truth for device compatibility and performance is established through engineering measurements and material standards. The expertise involved would be in manufacturing, quality control, and metrology, but no specific number or qualifications of "experts" are listed in this context.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This is not applicable to the type of study described. There's no clinical "adjudication" of results in a diagnostic or therapeutic sense. The "adjudication" of fit is based on optical measurements and cross-assembly, which are objective engineering assessments.
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:
- No. An MRMC study is relevant for evaluating diagnostic systems, especially those involving human interpretation (e.g., radiologists reading images with and without AI assistance). This submission is for a physical medical device (dental implant abutments and screws) and does not involve AI or human "readers" of any kind in a diagnostic capacity.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an algorithm or AI-based device. It is a physical dental implant component.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" in this context is based on engineering specifications, material standards (ASTM F136-08e1), precise measurements (using high-precision optical equipment), and successful physical cross-assembly with predicate devices/compatible implant systems. The compatibility is determined by mating diameters, lead-in bevels, internal/external hex sizes, and internal threads.
The sample size for the training set:
- This document describes the manufacture and testing of a physical medical device. It does not involve a "training set" in the context of machine learning or AI algorithms. The manufacturing process itself (machining, quality control) is analogous to "training" in that it produces the intended device, but it's not a data-driven training set.
How the ground truth for the training set was established:
- As there is no "training set" in the AI/machine learning sense, this question is not applicable. The "ground truth" for the device's design and manufacturing is established by engineering design specifications derived from the compatible predicate devices and relevant material standards. The manufacturing process aims to meet these specifications.

Summary

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Berkeley zimplant = Precision Implant Technology

342 Raritan Center Parkway, Edison, New Jersey 08837

K101068

Phone: 732-346-1000 Fax: 732-875-1169

510(K) Summary VI. -

	Company Name:	Radiant Express LLCDBA: Berkeley Implant
	Address:	342 Raritan Center ParkwayEdison, NJ 08837
	Telephone Number:	(732) 346-1000
	Fax Number:	(732) 875-1169
	Estab. Registration Number:	K101068
	Owner/Operator Number:	9087046
	Submitter's Name:	Ryan Chiou
	Contact Person:	Ryan Chiou
	Date Summary Prepared:	April 10, 2010
	Classification Name:	Abutment, Implant, Dental, Endosseous
	Common/Usual Name:	Endosseous dental implant abutment
	Device Trade Name:	AccuFitTM Dental Implant Abutments & Screws
	Predicate Devices:	See tables B & C below

1. Description:

Table A. Compatible Commercial Implant Manufacturers

Implant Company	Implant System	Implant Platform Diameter
Zimmer Dental	Tapered Screw-vent	3.5, 4.5, 5.7 mm
Nobel-Biocare	NobelReplace Select	3.5, 4.3, 5.0 mm
Biomet 3i	Osseotite Certain	3.4, 4.1, 5.0 mm
Lifecore	Renova (internal hex)	3.5, 4.5 mm
Biomedical	Restore (external hex)	3.3, 4.1, 5.0 mm

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342 Raritan Center Parkway, Edison, New Jersey 08837

2. Intended Use:

AccuFit™ Abutments and screws are intended to attach to an endosseous dental implant and provide support and retention for a single tooth and multiple teeth restoration in the mandible or maxilla.

AccuFit™ Screws are intended for securing a abutment onto an endosseous dental implant.

Implant Company	Implant System	Implant Platform Diameter
Zimmer Dental	Tapered Screw-vent	3.5, 4.5, 5.7 mm
Nobel-Biocare	NobelReplace Select	3.5, 4.3, 5.0 mm
Biomet 3i	Osseotite Certain	3.4, 4.1, 5.0 mm
Lifecore	Renova (internal hex)	3.5, 4.5 mm
Biomedical	Restore (external hex)	3.3, 4.1, 5.0 mm

Table A. Compatible Commercial Implant Manufacturers

3. Technological Characteristics:

The AccuFit™ abutments and screws are made of Titanium alloy Ti6Al4V using the same fabrication procedures as those of the predicate devices. The Titanium alloy used conforms to the following standard:

Standard	Description
ASTM F136-08e1	Standard Specification for Wrought Titanium-6 Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for SurgicalImplant Applications (UNS R56401)

4. Comparison Analysis:

The overall designs and technological characteristics of the AccuFit™ Abutment System are similar to that of the predicate devices. The materials used to manufacture the products and the indications for use are identical to the predicate devices.

To ensure compatibility, the following process is carried out:

The commercially available implant components are purchased as samples. .

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Berkeley implant = Precision Implant Technology

ਾ

342 Raritan Center Parkway, Edison, New Jersey 08837

The samples are measured using high-precision optical equipments, and the products are . machined using equipments capable of precision of um.
As a quality control step, the components produced are cross-assembled with the 0 commercially acquired samples. Screws are tightened to the amount of torque specified by the implant manufacturer. The interface between the components is then rechecked using the optical equipment to make sure precision fit is achieved.

Berkeley Implant monitors the compatible implants for modifications to ensure future compatibility. In the event of any modification by the original manufacturers, Berkeley Implant will either modify the AccuFit" abutment to ensure compatibility, or cease claiming compatibility to the modified implants.

The tables below summarize AccuFit" Abutments & Screws and the predicate devices' K numbers.

AccuFit Device	Predicate Device	K# forPredicate	Material
Preformed, stockTitaniumAbutments &Screws	Zimmer Tapered Screw-vent Hex-lockabutments & screws	K061410,K011028	Same as predicate devices:Abutment - Titanium Alloy Ti6Al4V Screw - Titanium Alloy Ti6Al4V
	Nobel-Biocare NobelReplace SelectAbutments and Screws	K021584
	Biomet 3i GingiHue Post & Screw	K072642,K063403
	Lifecore Renova & Restore Abutments	K032774,K965135
	Diamodent Compatible Abutments	K034022,K010619,K993129

Table B: AccuFit TM Preformed Stock Abutments and Predicate Devices' K-numbers

While some of the predicate devices use sterilized packaging and some do not, the AccuFit™ abutments use non-sterile packaging and provide detailed instructions on sterilizing procedures.

5. CONCLUSION

The evaluation of the AccuFit™ Abutment System does not raise any additional concerns regarding safety a d effectiveness and therefore is considered substantially equivalent to the predicate device.

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Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is black. The text is likely part of a document or sign.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Ryan Chiou President Radiant Express LLC 342 Raritan Center Parkway Edison, New Jersey 08837

AUG 2 3 2010

Re: K101068

Trade/Device Name: AccuFit" Dental Implant Abutments and Screws Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: August 5, 2010 Received: August 9, 2010

Dear Mr. Chiou:

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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Page 2- Mr. Chiou

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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K101068

Statement of Indications for Use V.

510(k) Number (if known): K101068

Device Name:

AccuFit™ Dental Implant Abutments and Screws

Indications For Use:

AccuFit™ Abutments and screws are intended to attach to an endosseous dental implant and provide support and retention for a single tooth and multiple teeth restoration in the mandible or maxilla.

AccuFit™ Screws are intended for securing a abutment onto an endosseous dental implant.

Table A. Compatible Commercial Implant Manufacturers

Implant Company	Implant System	Implant Platform Diameter
Zimmer Dental	Tapered Screw-vent	3.5, 4.5, 5.7 mm
Nobel-Biocare	NobelReplace Select	3.5, 4.3, 5.0 mm
Biomet 3i	Osseotite Certain	3.4, 4.1, 5.0 mm
Lifecore Biomedical	Renova (internal hex)	3.5, 4.5 mm
	Restore (external hex)	3.3, 4.1, 5.0 mm

Prescription Use X AND/OR Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

Resin Mulvey for MSM

(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K101068

Regulation Number and Section

§ 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.)