(100 days)
None
Not Found
No
The document describes a physical dental abutment and its intended use, with no mention of software, algorithms, or any technology related to AI or ML.
No
Explanation: The device is an abutment for dental implants, described as an accessory to support a prosthetic device. It does not directly treat or prevent a disease or condition.
No
Explanation: The device is described as an abutment intended to support a prosthetic device on dental implants. Its function is mechanical support, not to diagnose a condition or disease.
No
The device description clearly states it consists of physical components (abutments, titanium insert, abutment screw) and is intended to support a prosthetic device, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an accessory to dental implants to support a prosthetic device in a patient. This describes a device used in vivo (within the body) for structural support.
- Device Description: The description details the physical components of the abutment and screw, which are mechanical parts for dental restoration.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used to perform tests on samples taken from the body, not to be implanted into the body for structural support.
N/A
Intended Use / Indications for Use
BIOMET 3i Certain® Contoured Margin Ceramic Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or contains patient. The Certain® Contoured Margin Ceramic Abutments are intended for use support single and multiple tooth prostheses, in the mandible or maxilla. The prosthesis is ment retained to the abutment.
Product codes
NHA
Device Description
The BIOMET 3i Certain® Contoured Margin Ceramic Abutment design consists of The BIOME I 37 Certains Contoured in buttent screw. These devices worldwords ffferent abutments $125, thanimi insort and all about - 11.00 as 1000 as 1000 and and propriate reatures and 311 with internal connections.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandible or maxilla
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
BIOMET 3i Dental Ceramic Abutment, Zimmer® Contour Ceramic Abutment
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.)
0
Ko 73345
ROMET 31
MAR - 7 2008
510(k) SUMMARY
BIOMET 3i Contoured Margin Ceramic Abutment
BIOMET 3i, Inc.
Priscilla Caro
BIOMET 3i, Inc. Riverside Dr
Tel. 561-776-6785 Fax 561-514-6316
bmitter:
4555 Riverside Dr Palm Beach Gardens, FL 33410
Regulatory Affairs Specialist
Palm Beach Gardens, FL 33410
ntact Person:
ate Prepared:
ame of Device
rade/Proprietary Name: ommon/Usual Name
Slassification Name
assification
November 27, 2007
Certain® Contoured Margin Ceramic Abutment
Not available
Abutment, implant, dental, endosseous
Class II 21CFR 872.3630
oduct Code
edicate Devices
NHA
BIOMET 3i Dental Ceramic Abutment Zimmer® Contour Ceramic Abutment
tended Use / Indications for Use
BIOMET 31 Certain® Contoured Margin Ceramic Abutments are intended for use as an cessory to endosseous dental implants to support a prosthetic device in a partially or contains patient. The Certain® Contoured Margin Ceramic Abutments are intended for use support single and multiple tooth prostheses, in the mandible or maxilla. The prosthesis is ment retained to the abutment.
1
echnological Characteristics
The BIOMET 3i Certain® Contoured Margin Ceramic Abutment design consists of The BIOME I 37 Certains Contoured in buttent screw. These devices worldwords ffferent abutments $125, thanimi insort and all about - 11.00 as 1000 as 1000 and and propriate reatures and 311 with internal connections.
ubstantial Equivalence
The BIOMET 3i Certain® Contoured Margin Ceramic Abutments substantially equivalent o the BIOMET 37 Certain® Contouroum Margin Corants and Zimmer® Contour Ceramic of the predicate DrOWLY 37 Denat Condid uses, indications, technological characteristics, Abuttlent having the same general internets assoss, increased on the minor technological differences wetween the proposed devices components and their predicate devices raise no new issues of afety or effectiveness.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 7 2008
Ms. Priscilla Caro Regulatory Affairs Specialist Biomet 3i, Incorporated 4555 Riverside Drive Palm Beach Gardens, Florida 33410
Re: K073345
Trade/Device Name: Certain® Contoured Margin Ceramic Abutment Regulation Number: 21 CFR 872,3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: February 29, 2008 Received: March 3, 2008
Dear Ms. Caro:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2 - Ms. Caro
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sylvie Y. Mohano
md.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
BOMET 31
cations for Use
Number (if known):
novice Name: Certain® Contoured Margin Ceramic Abutment
Hons for Use:
on BE 3i Certain® Contoured Margin Ceramic Abutments are intended for use as an to endosseous dental implants to support a prosthetic device in a partially or continus patient. The Certain® Contoured Margin Ceramic Abutments are intended for use to more single and multiple tooth prostheses, in the mandible or maxilla. The prosthesis is and retained to the abutment.
INFY WHETHER THE DEVICE IS INTENDED FOR PRESCRIPTION USE DOR OVER-THE-COUNTER USE.]
cription Use & 1 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
ISE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Rumore
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K672245
Page
of