(96 days)
Not Found
No
The document describes a simple plastic cap for dental use and contains no mention of AI, ML, or related technologies.
No.
The primary purpose of the device is to prevent irritation and lodging of material during fabrication of a provisional restoration, not to treat a disease or condition.
No
The device description and intended use clearly state that the Zimmer Contour Provisional Coping is a "smooth plastic cap" used to prevent irritation, prevent material lodging, and for fabricating provisional restorations. It is a physical part for dental procedures, not a tool for identifying or characterizing a disease or condition.
No
The device is described as a "smooth plastic cap" and a "tan, textured, plastic cap," indicating it is a physical, hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used in the mouth to protect soft tissue, prevent material lodging, and facilitate the fabrication of a provisional restoration. This is a direct interaction with the patient's body and a mechanical function.
- Device Description: The device is described as a plastic cap that fits over an abutment or implant. This is a physical component used in a dental procedure.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease.
IVD devices are used to perform tests on samples like blood, urine, or tissue outside the body to gain diagnostic information. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Zimmer Contour Provisional Coping 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, to prevent material from lodging in any undercuts or openings, and for fabricating a cement-retained provisional restoration. Use of the provisional coping is not to exceed 180 days.
The Short Provisional Coping is for use with a Short Hex-Lock Abutment to prevent irritation of soft tissue due to rubbing against the restorative area of the abutment or implant, to prevent material from lodging in any undercuts or openings, and for fabricating a cement-retained provisional restoration. Use of the provisional coping is not to exceed 180 days.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The Contour Provisional Coping is a smooth plastic cap that fits passively over the cone of a Hex-Lock Contour Abutment or a Zimmer One-Piece Implant and mates with the margin of the abutment or implant abutment Implant and mates with the margin of the abutment or implant abutment section. Each passive fit cap is affixed to the abutment/implant cone with appropriate dental adhesive material selected by the clinician.
The Short Provisional Coping is a tan, textured, plastic cap that fits passively over the cone of a Hex-Lock® Short Abutment and mates with the margin of the abutment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Non-Clinical Testing: Non-clinical test data was not used to support the decision of safety and effectiveness. Clinical literature and material mechanical prosperities indicated that the device is strong enough to withstand the anticipated forces and demonstrated improvements over the predicate devices.
Clinical Testing: No clinical testing was performed. Non-clinical testing was used to support the decision of safety and 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.
K061043, K090723, K092377, K061043, K090723
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.
Not Found
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.)
0
Zimmer Dental
510k No.: K1130
1900 Aston Avenue Carlsbad, CA 92008 760.431.7811 (fax)
JAN 2 3 2012
A.5
Image /page/0/Picture/5 description: The image shows the logo for Zimmer Dental. The logo features a stylized letter "Z" inside of a circle. Below the circle, the word "zimmer" is written in a serif font, with a line underneath it, and the word "dental" is written in a sans-serif font below the line.
Traditional 510(k) PRE-MARKET NOTIFICATION 510(k)
510(k) SUMMARY (21CFR807.92(a))
1. Submitter's Information:
Zimmer Dental Inc. Name:
Address: 1900 Aston Ave. Carlsbad, CA 92008
760-929-4300 Phone:
Contact: Jeremy Markovich
Date Prepared: October 17, 2011
-
- New Device(s):
New Device No. 1 Trade Name: Zimmer® Contour Provisional Coping Regulation Number: 872.3630 Classification Code: NHA Device Classification Name: Endosseous Dental Implant Abutment
- New Device(s):
New Device No. 2 Zimmer® Short Provisional Coping Trade Name: Regulation Number: 872.3630 NHA Classification Code: Device Classification Name: Endosseous Dental Implant Abutment
- క. Predicate Device(s):
Predicate Device No. 1 Zimmer® Contour Provisional Coping Trade Name: K061043 510(k) Number: Regulation Number: 872.3630 Classification Code: NHA Device Classification Name: Endosseous Dental Implant Abutment
1
| Zimmer Dental | 510k No.: | ||
|---|---|---|---|
| 1900 Aston Avenue | Page No.: | A.5 | |
| Carlsbad, CA 92008 | |||
| 760.929.4300 (ph) | |||
| 760.431.7811 (fax) |
Predicate Device No. 2
| Trade Name: | Zimmer® Short Provisional Coping |
|---|---|
| 510(k) Number: | K090723 |
| Regulation Number: | 872.3630 |
| Classification Code: | NHA |
| Device Classification Name: | Endosseous Dental Implant Abutment |
Predicate Device No. 3
| Trade Name: | Zimmer® Plastic Temporary Abutment |
|---|---|
| 510(k) Number: | K092377 |
| Regulation Number: | 872.3630 |
| Classification Code: | NHA |
| Device Classification Name: | Endosseous Dental Implant Abutment |
Predicate Device No. 4
| Trade Name: | Zimmer® Contour Healing Cap |
|---|---|
| 510(k) Number: | K061043 |
| Regulation Number: | 872.3630 |
| Classification Code: | NHA |
| Device Classification Name: | Endosseous Dental Implant Abutment |
Predicate Device No. 5
| Trade Name: | Zimmer® Short Healing Cap |
|---|---|
| 510(k) Number: | K090723 |
| Regulation Number: | 872.3630 |
| Classification Code: | NHA |
| Device Classification Name: | Endosseous Dental Implant Abutment |
- Device Description:
The Contour Provisional Coping is a smooth plastic cap that fits passively over the cone of a Hex-Lock Contour Abutment or a Zimmer One-Piece Implant and mates with the margin of the abutment or implant abutment
Implant and mates with the margin of the abutment or implant abutment section. Each passive fit cap is affixed to the abutment/implant cone with appropriate dental adhesive material selected by the clinician.
The Short Provisional Coping is a tan, textured, plastic cap that fits passively over the cone of a Hex-Lock® Short Abutment and mates with the margin of the abutment.
Indication for Use: 5.
The Zimmer Contour Provisional Coping 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
2
| 510k No.: | |
|---|---|
| Page No.: | A.5 |
1900 Aston Avenue Carisbad, CA 92008 760.929.4300 (ph) 760.431.7811 (fax)
implant, to prevent material from lodging in any undercuts or openings, and for fabricating a cement-retained provisional restoration. Use of the provisional coping is not to exceed 180 days.
The Short Provisional Coping is for use with a Short Hex-Lock Abutment to prevent irritation of soft tissue due to rubbing against the restorative area of the abutment or implant, to prevent material from lodging in any undercuts or openings, and for fabricating a cement-retained provisional restoration. Use of the provisional coping is not to exceed 180 days.
6. · Device Comparison:
Zimmer Dental Inc. believes the Zimmer® Contour Provisional Coping and Zimmer® Short Provisional Coping to be substantially equivalent to their respective predicates as listed below. The modified devices are not subject to geometry modification and will be manufactured using the same process. The modified devices are equivalent in intended use, design. and materials. PEEK (polyether ether ketone) material demonstrates an improvement in functional performance compared to Ultem and PMMA. The modifications affect product labeling; however, these changes do not bring up new concerns regarding safety and efficacy and no new risks have been identified.
| Feature: | New Device 1: | Predicate No. 1: | Predicate No. 2: | Predicate No. 3: |
|---|---|---|---|---|
| Contour Provisional | ||||
| Coping | Contour Provisional | |||
| Coping | Zimmer Plastic | |||
| Temporary | ||||
| Abutment | Zimmer Contour | |||
| Healing Cap | ||||
| Material | PEEK (polyether | |||
| ether ketone) | Ultem 1010-1101 | |||
| (polyetherimide) | PEEK (polyether | |||
| ether ketone) | PMMA Acrylic | |||
| CP-1000-IG | ||||
| Fit | Mates uniquely with | |||
| shape of Contour | ||||
| abutment. | Mates uniquely with | |||
| shape of Contour | ||||
| abutment. | Hexagon | |||
| connection | Mates uniquely | |||
| with shape of | ||||
| Contour | ||||
| abutment. | ||||
| Design | ||||
| Feature | Has indexing / anti | |||
| rotation feature | Has indexing / anti | |||
| rotation feature | Straight or angled, | |||
| collar heights in 1 | ||||
| or 4mm. Grooves | ||||
| for retention, | ||||
| defined margin | Has indexing / | |||
| anti rotation | ||||
| feature | ||||
| Feature: | New Device 2: | Predicate No. 1: | Predicate No. 2: | Predicate No. 3: |
| Short Provisional | ||||
| Coping | Short Provisional | |||
| Coping | Zimmer Plastic | |||
| Temporary | ||||
| Abutment | Short Healing Cap | |||
| Material | PEEK (polyether | |||
| ether ketone) | Ultem 1010-1101 | |||
| (polyetherimide) | PEEK (polyether | |||
| ether ketone) | PMMA Acrylic | |||
| CP-1000-IG | ||||
| Fit | Mates uniquely with | |||
| shape of short | ||||
| abutment. | Mates uniquely with | |||
| shape of short | ||||
| abutment. | Hexagon | |||
| connection | Mates uniquely | |||
| with shape of | ||||
| Short abutment. |
7. Technological Characteristics
3
| Design
Feature | Has indexing / anti
rotation feature | Has indexing / anti
rotation feature | Straight or angled,
collar heights in 1
or 4mm. Grooves
for retention,
defined margin | Has indexing /
anti rotation
feature |
| ------------------- | ----------------------------------------- | ----------------------------------------- | --------------------------------------------------------------------------------------------------- | -------------------------------------------- |
|---|
Non-Clinical Testing: 8.
Non-clinical test data was not used to support the decision of safety and effectiveness. Clinical literature and material mechanical prosperities indicated that the device is strong enough to withstand the anticipated forces and demonstrated improvements over the predicate devices.
9. Clinical Testing
No clinical testing was performed. Non-clinical testing was used to support the decision of safety and effectiveness.
Conclusion 10.
Based on our analysis, the device is substantially equivalent to the predicates and it is considered that the new device is as safe and effective for its intended use and performs as well or better than the predicate device(s).
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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines forming the wings and a snake winding around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Jeremy Markovich Regulatory Affairs Zimmer Dental Incorporated 1900 Aston Avenue Carlsbad. California 92008
JAN 2 3 2012
Re: K113092
Trade/Device Name: Zimmer® Contour Provisional Coping Zimmer® Short Provisional Coping Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: January 11, 2012 Received: January 17, 2012
Dear Mr. Markovich:
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. 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 Federal Register.
5
Page 2 - Mr. Markovich
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 vours.
Nr for
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
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Image /page/6/Picture/0 description: The image shows a logo for Zimmer Dental. The logo consists of a stylized letter "Z" inside a circle, with the word "zimmer" written in lowercase letters below it. Underneath "zimmer" is the word "dental" in a smaller font size. The logo appears to be for a dental-related company or service.
510k No.: A4-1 Page No .:
Zimmer® Contour Provisional Coping Zimmer® Short Provisional Coping
Indications for Use
510(k) Number (if known): _
Device Name: Zimmer® Contour Provisional Coping Zimmer® Short Provisional Coping
Indications For Use:
The Zimmer Contour Provisional Coping 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, to prevent material from lodging in any undercuts or openings, and for fabricating a cement-retained provisional restoration. Use of the provisional coping is not to exceed 180 days.
The Short Provisional Coping is for use with a Short Hex-Lock Abutment to prevent irritation of soft tissue due to rubbing against the restorative area of the abutment or implant, to prevent material from lodging in any undercuts or openings, and for fabricating a cement-retained provisional restoration. Use of the provisional coping is not to exceed 180 days.
1 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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Swear Puane
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K113092