(74 days)
Not Found
No
The document describes physical dental devices (healing collars, caps, and copings) used for shaping gingival tissue and fabricating provisional restorations. There is no mention of software, algorithms, image processing, AI, ML, or data sets.
No
The device aids in the preparation of dental prostheses and forms gingival tissue, which are not considered therapeutic actions.
No
The device description and intended use state that it is used to shape gingival tissue, prevent irritation, and aid in fabricating dental prostheses. It does not mention diagnosing any conditions or diseases.
No
The device description explicitly states the devices are available in titanium or acrylic, indicating they are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Zimmer Contour Restorative System devices (Healing Collar, Healing Cap, Provisional Coping) are used directly in the mouth to shape tissue, protect tissue, and fabricate temporary restorations around dental implants. They are physical devices used for mechanical and structural purposes within the body.
- Intended Use: The intended uses described are all related to shaping and protecting oral tissues and fabricating temporary dental prostheses. None of these involve testing samples from the body.
Therefore, the Zimmer Contour Restorative System falls under the category of a dental device used for restorative and surgical purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Zimmer® Contour Healing Collar is used to shape the gingival tissue during healing to allow for a suitable emergence profile of the prosthesis.
The Zimmer® Contour Healing Cap is for use with a Hex-Lock™ Contour Abutment or a Zimmer® One-Piece Implant to prevent irritation of soft tissue due to rubbing against the restorative area of the abutment or implant, and to prevent material from lodging in any undercuts or openings.
The Zimmer® Contour Provisional Coping is used for fabricating a cement-retained provisional restoration for a Hex-Lock™ Contour Abutment or a Zimmer® One-Piece Implant. Use of the provisional cap is not to exceed 28 days.
Product codes
NHA
Device Description
The Zimmer Contour Restorative System is used to aid in the preparation of dental prostheses, as well as, to form the gingival tissue around an endosseous implant site prior to prosthesis fixation. The system is used with Zimmer Dental abutment-endosseous dental implant combinations, as well as, the Zimmer® One-Piece Implant. Devices are available in titanium or acrylic.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gingival tissue around an endosseous implant site
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
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
Image /page/0/Picture/0 description: The image shows the logo for Zimmer Dental. The logo consists of a circle with a large, bold letter "Z" inside. Below the circle, the word "zimmer" is written in a stylized font. Underneath "zimmer", the word "dental" is written in a smaller, simpler font.
Zimmer Dental
1900 Aston Avenue
Carlsbad, CA 92008 760.929.4300 (ph)
510k No .:
Page No .: A5-1
JUN 2 7 2006
510(k) SUMMARY (21CFR807.92(a))
-
- Submitter's Information:
| Name: | Zimmer Dental Inc. |
|---|---|
| Address: | 1900 Aston Ave. |
| Carlsbad, CA 92008 | |
| Phone: | 760-929-4300 |
| Contact: | Erin L. McVey |
| Date Prepared: | April 12, 2006 |
- Zimmer® Contour Restorative System Device Name:
Device Classification Name: Endosseous Dental Implant Abutment
-
- Predicate Device(s):
- . Zimmer Dental Advent® Implant Extender/ Healing Collar
- . 3i EP Two Piece Healing Abutment
- Lifecore Quick-Abutment Temporary/ Healing Cap .
- Zimmer Dental Pure Form Ceramic Coping .
-
- Device Description:
The Zimmer Contour Restorative System is used to aid in the preparation of dental prostheses, as well as, to form the gingival tissue around an endosseous implant site prior to prosthesis fixation. The system is used with Zimmer Dental abutment-endosseous dental implant combinations, as well as, the Zimmer® One-Piece Implant. Devices are available in titanium or acrylic.
- ട്. Intended Use:
The Zimmer® Contour Healing Collar is used to shape the gingival tissue during healing to allow for a suitable emergence profile of the prosthesis.
The Zimmer® Contour Healing Cap is for use with a Hex-Lock™ Contour Abutment or a Zimmer® One-Piece Implant to prevent irritation of soft tissue due to rubbing against the restorative area of the abutment or implant, and to prevent material from lodging in any undercuts or openings.
The Zimmer® Contour Provisional Coping is used for fabricating a cement-retained provisional restoration for a Hex-Lock™ Contour Abutment or a Zimmer® One-Piece Implant. Use of the provisional cap is not to exceed 28 days.
- Device Comparison: 6.
Zimmer Dental Inc. believes the Zimmer® Contour Healing Collar. Healing Cap and Provisional Coping to be substantially equivalent to their respective predicates. They are equivalent in intended use, design, and materials.
1
Image /page/1/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract image of an eagle, represented by three curved lines. The eagle is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 27 2006
Mr. Eric L. McVev Regulatory Affairs Specialist Zimmer Dental, Incorporated 1900 Aston Avenue Carlsbad, California 92008-7308
Re: K061043
Trade/Device Name: Zimmer® Contour Restorative System Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: June 12, 2006 Reccived: June 15, 2006
Dear Mr. McVey:
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 H (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.
2
Page 2 -- Mr. McVey
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 cntitled, "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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Clare
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
3
Indications for Use
510(k) Number (if known):
Device Name: Zimmer® Contour Healing Collar Zimmer® Contour Healing Cap Zimmer® Contour Provisional Coping
Indications For Use:
The Zimmer® Contour Healing Collar is used to shape the gingival tissue during healing to allow for a suitable emergence profile of the prosthesis.
The Zimmer® Contour Healing Cap is for use with a Hex-Lock™ Contour Abutment or a Zimmer® One-Piece Implant to prevent irritation of soft tissue due a more against the restorative area of the abutment or implant, and to prevent materials from lodging in any undercuts or openings.
The Zimmer® Contour Provisional Coping is used for fabricating a cement one neg provisional restoration for a Hex-Lock™ Contour Abutment or a Zimment of College Implant. Use of the provisional coping is not to exceed 28 days.
× Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Union ... .. (21 CFR 801 Subpart C :
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER FOR A NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sunil Kumar
13 hasiology, General Hospital, n Continel, Dental Devic
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