(111 days)
No
The summary describes a standard dental implant system and its components, with no mention of AI, ML, image processing, or any related computational technologies. The performance studies focus on material properties and mechanical testing.
Yes
The dental implant system is used to restore patient chewing function, which is a physiological process. The restoration of function is a characteristic of a therapeutic device.
No
The device description and intended use focus on surgical and restorative applications to support prosthetic devices, not on diagnosing medical conditions.
No
The device description explicitly lists physical components such as implants, screws, caps, abutments, superstructures, and surgical instruments, indicating it is a hardware-based medical device system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used in vivo (within the body) for surgical and restorative purposes to support prosthetic devices and restore chewing function. IVDs are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The components listed (implants, screws, caps, abutments, instruments) are all physical devices designed for implantation and surgical procedures, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), reagents, calibrators, controls, or any other elements typically associated with IVD devices.
Therefore, the BHdental Implant System is a medical device used for surgical and restorative procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone of the upper or lower jaw
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
All these tests demonstrate that the BHdental Implant System is substantially equivalent to its predicates without raising new issues of safety or effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K080156, K091239, K071803, K071370
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.)
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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 Ezra
Duet Medical Consulting Ltd.
21 Hanafa Street
Zur- 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:
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.
5.13 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.
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:
-
- FDA Guidance Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments
-
- ISO 14801:2007 "Dentistry-Implants-Dynamic fatigue test for endosseous dental implants"
-
- ISO 5832-3:1996 Implants for surgery -- Metallic materials -- Part 3: Wrought titanium 6-aluminium 4-vanadium alloy
-
- ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications
-
- ASTM F899 Standard Specification for Wrought Stainless Steels for Surgical Instruments
-
- ISO 7405:2008 Dentistry -- Evaluation of biocompatibility of medical devices used in dentistry
-
- ASTM F746-04 (Reapproved 2009)- Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials
-
- 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):