The intended use of Steri-Oss' Bio-Esthetic Indirect Abutment, an abutment retained with a lingual retaining screw, is to provide a stable, secure foundation upon which a prosthetic appliance (the purpose of which is restoration of masticatory function in the edentulous or partially edentulous patient) can be attached, yet remain retrievable.

Device Description

How device functions: The Steri-Oss Lingual Bio-Esthetic Indirect Abutment is designed to be used in conjunction with endosseous implants as part of a system to provide support for prosthetic appliances to restore patient chewing function, and includes utilization of a lingual refaining screw for abutment retention which allows retrievability.

Scientific concepts; Natural dentition is composed of a root (subgingival) and a crown (supragingival). Implant system designs in existence are intended to mimic this structure to aid the patient in restoring natural masticatory function. The implant is designed to serve as the root of the artificial tooth and the abutment/prosthetic is designed to serve as the crown. The abutment must be securely fastened to the implant. A lingual retaining screw may be used for this purpose, while retaining retrievability.

Characteristics: The Bio-Esthetic Indirect Abutment is a conventional abutment designed for use with a lingual screw which, when tightened, retains the abutment in place.

AI/ML Overview

Here's a breakdown of the requested information based on the provided 510(k) summary for the Bio-Esthetic Indirect Abutment:

1. Table of Acceptance Criteria and Reported Device Performance:

Characteristic	Predicate Device (Friatec's "Frialit MH-6 Abutment")	New Device (Steri-Oss' Bio-Esthetic Indirect Abutment)	Acceptance Criteria (Implicit from Substantial Equivalence Claim)
Abutment and Screw Material	Titanium alloy	Titanium alloy	Same as predicate (Titanium alloy)
Retaining Screw Collar Material	Gold alloy	Gold alloy	Same as predicate (Gold alloy)
Abutment Design	Cylindrical shape	Oval cylinder shape with and without angulation	Considered acceptable if it provides similar function and safety to predicate
Height (mm)	0.130 in. to 0.256 in.	0.350 in. to 0.0359 in.	Considered acceptable if it provides similar function and safety to predicate
Maximum Diameter (mm)	0.067 in. to 0.110 in.	0.230 in. to 0.283 in.	Considered acceptable if it provides similar function and safety to predicate
Abutment Angulation	Straight	Straight and 15°	Considered acceptable if it provides similar function and safety to predicate
Packaging	Unknown	Chevron pouch in plastic case	Not explicitly stated as a comparative performance metric for function, but assumed to be adequate for device protection and sterility maintenance if applicable.
Sterility	Unknown	Provided Sterile	Assumed to meet applicable sterility standards.

Study Proving Device Meets Acceptance Criteria:

The 510(k) submission states: "Performance Data: Not applicable." This explicitly indicates that no performance study (clinical or non-clinical) was conducted or provided to demonstrate that the device meets specific acceptance criteria in the traditional sense of a study with defined endpoints and statistical analysis.

Instead, the submission relies on the concept of substantial equivalence to a predicate device (Friatec's "Frialit-2 MH-6 Abutment"). The acceptance criteria are implicitly met by demonstrating that the new device has the same or similar technological characteristics and intended use as the legally marketed predicate device, and does not raise different questions of safety and effectiveness.

Therefore, the "study" that proves the device meets the acceptance criteria is the comparison to the predicate device as presented in Table 6.1 and the accompanying textual description. The FDA's issuance of the 510(k) clearance signifies their agreement that, based on this comparison, the new device is substantially equivalent to the predicate.

2. Sample size used for the test set and the data provenance:

Sample Size: Not applicable, as no performance study with a test set was conducted.
Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable, as no performance study with a test set requiring ground truth establishment was conducted.

4. Adjudication method for the test set:

Not applicable, as no performance study with a test set was conducted.

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:

No, an MRMC comparative effectiveness study was not done. This device is a dental implant abutment, not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

No, a standalone performance study was not done. This device is a physical medical device, not an algorithm.

7. The type of ground truth used:

Not applicable, as no performance study requiring ground truth was conducted. The "ground truth" for substantial equivalence is the predicate device's established safety and effectiveness.

8. The sample size for the training set:

Not applicable, as this is a physical medical device, not a machine learning model requiring a training set.

9. How the ground truth for the training set was established:

Not applicable, as this is a physical medical device, not a machine learning model.

Summary

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Original 510(k) Bio-Esthetic Indirect Abutment

Ka700073

Section 6 510(k) Summary பரா - 3 பத்து

letterhead

510(k) Summary

Manufacturer Information:

Submitter's Name:	Steri-Oss Inc.
Address:	22895 Eastpark Drive
	Yorba Linda, CA 92887, U.S.A.
Contact's Name:	Jeff Hausheer, Ph.D.
	Regulatory Affairs Specialist
Phone:	714-282-4800, extension 3815
Date Prepared:	January 1997

Device Names:

Common Name: Endosseous Dental Implant Abutment and Lingual Retaining Screw

Trade Name: Bio-Esthetic Indirect Abutment

Classification Name: Endosseous implant

Predicate Device:

Substantial equivalence is claimed to Friatec's "Frialit-2 MH-6 Abutment".

Device Description:

Page 1 of 3

Steri-Oss Inc. - January 1997

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Original 510(k) Bio-Esthetic Indirect Abutment

Section 6 510(k) Summary (continued)

letterhead

510(k) Summary (continued)

Device Description (continued):

Characteristics: The Bio-Esthetic Indirect Abutment is a conventional abutment designed for use with a lingual screw which, when tightened, retains the abutment in place.

Intended Use:

Comparison to Predicate:

Table 6.1 provides a comparison of the technological characteristic of the Steri-Oss implant to the predicate.

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Section 6 510(k) Summary (continued)

Table 6.1

Product Comparison - Abutment with Lingual Retaining Screw

Characteristic	PREDICATEFriatec's"Frialit MH-6 Abutment"	NEW DEVICESteri-Oss'Bio-Esthetic Indirect Abutment
Abutment and Screw Material	Titanium alloy	Same
Retaining Screw Collar Material	Gold alloy	Gold alloy
Abutment Design	Cylindrical shape	Oval cylinder shape with andwithout angulation
Height (mm)	0.130 in. to 0.256 in.	0.350 in. to 0.0359 in.
Maximum Diameter (mm)	0.067 in. to 0.110 in.	0.230 in. to 0.283 in.
Abutment Angulation	Straight	Straight and 15°
Packaging	Unknown	Chevron pouch in plastic case
Sterility	Unknown	Provided Sterile

Performance Data:

Not applicable.

Page 3 of 3

Steri-Oss Inc. - January 1997

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle faces to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

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

SEP 1 7 2010

Ms. Phuong Nguyen Son Regulatory Affairs Manager Nobel Biocare USA. LLC 22715 Savi Ranch Parkway Yorba Linda, California 92887

Re: K970073

Trade/Device Name: Bio-Esthetic Indirect Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Bio-Esthetic Indirect Abutment Regulatory Class: II Product Code: NHA Dated: July 28, 2010 Received: July 29, 2010

Dear Ms. Nguyen Son:

This letter corrects our substantially equivalent letter of July 28, 2010.

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 (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.

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- Ms. Nguyen Son

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Susan Runoey

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control Office of Device Evaluation Center for Devices and Radiological Health

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Original 510(k) Bio-Esthetic Indirect Abutment

Section 9

Indications for Use

Page 1 of 1

510(k) Number (if known): _ K970073_

Device Name: Bio-Esthetic Indirect Abutment

Indications For Use:

The intended use of Steri-Oss' Bio-Esthetic Indirect Abutment retained with a lingual retaining screw, is to provide a stable, secure foundation upon which a prosthetic appliance (the purpose of which is restoration of masticatory function in the edentulous and partially edentulous patient) can be attached, yet remain retrievable.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Signature

(Division Sign-Off)

Division of Dental, Infection Control,

and General Hospital Devices

510(k) Number	K970073
---------------	---------

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	OR Over-The-Counter Use ____ (Per 21 CFR 801.109)
-----------------------------------------------------	---------------------------------------------------

(Optional Format 1-2-96)

Steri-Oss inc. - January 1997

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.)