The BHdental Implant system is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient chewing function. The BHdental Implant System is also indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Device Description

The BHdental Implant System consists of one and two stage endosseous form dental implant, internal and external hexagonal; internal octagonal; cover screws and healing caps; abutment systems, superstructures and surgical instruments.

AI/ML Overview

The provided text describes the BHdental Implant System, which is a dental implant device. For medical devices like this, "acceptance criteria" and "device performance" are typically demonstrated through compliance with recognized standards and specific performance testing, rather than through studies involving human test sets, expert ground truth, or AI comparative effectiveness as would be common for diagnostic AI software.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard / Test)	Reported Device Performance
FDA Guidance: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments	"The device complies with the following standards" - Implies compliance.
ISO 14801:2007 "Dentistry-Implants-Dynamic fatigue test for endosseous dental implants"	"A series of safety and performance testing were performed to demonstrate that the BHdental Implant System does not raise any new issues of safety and efficacy. These tests include: fatigue..." - Implies compliance through testing.
ISO 5832-3:1996 Implants for surgery -- Metallic materials -- Part 3: Wrought titanium 6-aluminium 4-vanadium alloy	"The device complies with the following standards" - Implies compliance.
ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI Alloy for Surgical Implant Applications	"The device complies with the following standards" - Implies compliance.
ASTM F899 Standard Specification for Wrought Stainless Steels for Surgical Instruments	"The device complies with the following standards" - Implies compliance.
ISO 7405:2008 Dentistry -- Evaluation of biocompatibility of medical devices used in dentistry	"A series of safety and performance testing were performed... These tests include: ...biocompatibility." - Implies compliance through testing.
ASTM F746-04 (Reapproved 2009) Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials	"A series of safety and performance testing were performed... These tests include: ..., corrosion resistance..." - Implies compliance through testing.
ISO 10993 -1:2003 Biological evaluation of medical devices -Part 1: Evaluation and testing	"The device complies with the following standards" - Implies compliance.
Specific Safety/Efficacy Areas: Fatigue, Corrosion Resistance, Biocompatibility	"A series of safety and performance testing were performed to demonstrate that the BHdental Implant System does not raise any new issues of safety and efficacy. These tests include: fatigue, corrosion resistance... and biocompatibility." - Indicates device was tested and found compliant.
Specific Manufacturing Process: Sand Blasting Process	"A series of safety and performance testing were performed... These tests include: ..., sand blasting process..." - Indicates process was evaluated for safety/efficacy aspects.

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

Test Set Sample Size: Not applicable in the context of this device and the provided documentation. The performance testing described is primarily mechanical, material, and biocompatibility testing, not clinical studies with human "test sets" in the diagnostic AI sense.
Data Provenance: Not applicable. The data comes from laboratory and material testing, not human patient data.

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

Not applicable. Ground truth for dental implant material and mechanical properties is established by the specifications in the standards (e.g., ISO, ASTM) and the results of laboratory tests performed by qualified technicians/engineers.

4. Adjudication method for the test set:

Not applicable. The "test set" consists of physical devices or materials undergoing engineered tests, not clinical cases requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging interpretation or other scenarios where human readers interact with AI, which is not the case for this dental implant device.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

The "ground truth" for this device is based on established engineering standards and material specifications (e.g., the strength required by ISO 14801 for fatigue, the chemical composition specified in ASTM F136, the biological response deemed safe by ISO 10993). Test results are compared against these predetermined specifications.

8. The sample size for the training set:

Not applicable. This device is not an AI model, so there is no "training set."

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

Not applicable. There is no AI training set.

Summary

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510(K) SUMMARY

510(K) Number K_10 3280

5.1 Applicant's Name:	BHdental Ltd.4 Hayetsira st.Nesher 36882 Israel.Tel/fax: +972 4 820 2882
5.2 Contact Person:	Eilat EzraDuet Medical Consulting Ltd.21 Hanafa StreetZur- Moshe 42810, ISRAEL

P.O.Box 536 T +972 54 242 2555 F +972 153 52 833 7207 Email: eilat@duet-medical.com

5.3 Date Prepared: October 2010
5.4 Trade Name: BHdental Implant System
5.5 Classification Name: Implant, Endosseous, Root-Form
5.6 Medical Specialty: Dental

5.7 Product Code: DZE

5.8 Device Class: Class II
5.9 Regulation Number: 872.3640
5.10 Review Panel: Dental

5.11 Predicate Devices:

Alpha-Bio Tec® Dental Implant System (Alpha-Bio Tec Ltd) cleared under o K063364; product code DZE (Implant, Endosseous, Root-Form)
ONEPLANT Dental Implant System (WARANTEC Co., Ltd.) cleared under . K081748; product code DZE (Implant, Endosseous, Root-Form) and NHA (Abutment, Implant, Dental, Endosseous)
MIS Dental Implant System (MIS Implant Technologies Ltd.) cleared . under K040807; product code DZE (Implant, Endosseous, Root-Form)

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Osseospeed TM Profile System (ASTRA Tech AB) cleared under o K080156, K091239) ; product code DZE (Implant, Endosseous, Root-Form)
ARSD Dental Implants (ARDS Ltd.) cleared under K071803 ;product code . DZE (Implant, Endosseous, Root-Form)
NobleActive internal Connection Implant (Nobel Biocare AB) cleared . under K071370;product code DZE (Implant, Endosseous, Root-Form); product code NHA (Abutment, Implant, Dental, Endosseous).

5.12 Intended Use / Indication for Use:

5.13 Device Description:

5.14 Substantial Equivalence:

The proposed BHdental Implant System has similar indications for use, technological characteristics, mode of operation and performance specification as the predicates Alpha-Bio Tec® Dental Implant System (K063364), ONEPLANT Dental Implant System (K081748) and MIS Dental Implant System (K040807).

The proposed device has the same intended use as the predicate Alpha-Bio Tec® Dental Implant System and MIS Dental Implant System and is placed using the same methodology as all of the predicate devices. Both the proposed and predicate devices function in the same manner providing support for prosthetic devices in the upper or lower jaw.

Performance Testing

A series of safety and performance testing were performed to demonstrate that the BHdental Implant System does not raise any new issues of safety and efficacy. These tests include: fatigue, corrosion resistance, sand blasting process and biocompatibility.

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The device complies with the following standards:

1. FDA Guidance Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments
1. ISO 14801:2007 "Dentistry-Implants-Dynamic fatigue test for endosseous dental implants"
1. ISO 5832-3:1996 Implants for surgery -- Metallic materials -- Part 3: Wrought titanium 6-aluminium 4-vanadium alloy
1. ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications
1. ASTM F899 Standard Specification for Wrought Stainless Steels for Surgical Instruments
1. ISO 7405:2008 Dentistry -- Evaluation of biocompatibility of medical devices used in dentistry
1. ASTM F746-04 (Reapproved 2009)- Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials
1. ISO 10993 -1:2003 Biological evaluation of medical devices -Part 1: Evaluation and testing

All these tests demonstrate that the BHdental Implant System is substantially equivalent to its predicates without raising new issues of safety or effectiveness.

Summary

Based on the performance testing results, and compliance to performance standards BHdental Ltd. believes that the Implant System is substantially equivalent to its predicates without raising new issues of safety or effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Public Health Service

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

BHdental. Limited C/O Mr. Eilat Ezra Duet Medical Consulting, Limited 21 Hanafa Street Zur-Moshe ISRAEL 42810

FEB 2 4 201

Re: K103280

Trade/Device Name: BHdental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Implant, Endosseous, Root-Form Regulatory Class: II Product Code: NHA. DZE Dated: February 16, 2011 Received: February 22, 2011

Dear Mr. Ezra:

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 provice 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 Fice in the Figeral Register.

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Page 2- Mr. Ezra

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/ucm 1 15809.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.

Suon Puars

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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INDICATIONS FOR USE

510(k) Number (if known): < 10328

Device Name: BHdental Implant System

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

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

510(k) Number

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.)