(90 days)
Not Found
Not Found
No
The document describes a physical dental implant abutment and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is a temporary dental implant abutment used to support provisional restorations during healing, not for treating or curing a disease.
No
The device, a Plastic Temporary Abutment, is used to fabricate and support provisional restorations during a healing period, not to diagnose a condition or disease. It is a temporary prosthetic component.
No
The device description clearly states it is a "Plastic Temporary Abutment," which is a physical component used in dental procedures. It is made of PEEK CLASSIX material and is available in different shapes and sizes. This is not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states the device is a "Plastic Temporary Abutment" used in dental procedures to support provisional restorations during the healing period after dental implant placement. It is a physical component placed within the mouth.
- Lack of Specimen Analysis: There is no mention of the device being used to analyze any biological specimens from the patient. Its function is mechanical support and aiding in tissue shaping.
Therefore, the device described is a dental prosthetic component, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Plastic Temporary Abutment is intended to be used to fabricate and support provisional restorations that aid in creating an esthetic emergence through the gingiva during the healing period and prior to final restoration. The Plastic Temporary Abutment can be used for cement-retained or screw-retained provisional restorations. The abutments can be used for single-unit and multi-unit restorations. Use of the Plastic Temporary Abutment is not to exceed one-hundred and eighty (180) days.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The Plastic Temporary Abutments are endosseous dental implant abutments that are designed for single use as a temporary prosthesis during the healing process while the permanent prosthesis is fabricated. The PEEK CLASSIX material, when utilized as a Temporary Abutment, can be placed in use for up to 180 days. They are available in straight and angled versions, with interfaces to match the three diameters of Tapered Screw-Vent Implants, and 1mm or 4mm cuff height options.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
gingiva (through the gingiva)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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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.)
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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.
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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.
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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
Image /page/0/Picture/0 description: The image shows the logo for Zimmer Dental. The logo consists of a circle with a stylized "Z" inside, above the word "zimmer" in a serif font. Below "zimmer" is the word "dental" in a sans-serif font.
| Zimmer Dental |
|---|
| --------------- |
K092377 510k No.:
A5-1 Page No.:
900 Aston Avenue Carlsbad, CA 92008 760.929.4300 (ph) 760.431.7811 (fax)
Traditional 510(k) PRE-MARKET NOTIFICATION 510(k)
NOV - 3 2009
510(k) SUMMARY (21CFR 807.92(a))
-
- Submitter's Information:
| Name: | Zimmer Dental Inc. |
|---|---|
| Address: | 1900 Aston Ave. |
| Carlsbad, CA 92008 | |
| Phone: | 760-929-4300 |
| Contact: | William Fisher |
| Date Prepared: | November 3, 2009 |
-
- Plastic Temporary Abutment Device Name: Device Classification Name: Endosseous Dental Implant Abutment Device Regulation Number : 872.3630 Product Code : NHA, Dental
- Hex-Lock® Temporary Abutment 3. Predicate Device(s): Friadent® EsthetiCap PreFormance Post
Device Description: 4.
The Plastic Temporary Abutments are endosseous dental implant abutments that are designed for single use as a temporary prosthesis during the healing process while the permanent prosthesis is fabricated. The PEEK CLASSIX material, when utilized as a Temporary Abutment, can be placed in use for up to 180 days. They are available in straight and angled versions, with interfaces to match the three diameters of Tapered Screw-Vent Implants, and 1mm or 4mm cuff height options.
Indications for Use: 5.
The Plastic Temporary Abutment is intended to be used to fabricate and support provisional restorations that aid in creating an esthetic emergence through the gingiva during the healing period and prior to final restoration. The Plastic Temporary Abutment can be used for cement-retained or screw-retained provisional restoration. The
1
510(k) No. A5-2 Page No. __
abutments can be used for single-unit and multi-unit restorations. Use of the Plastic Temporary Abutment is not to exceed one-hundred and eighty (180) days.
6. Device Comparison:
The Plastic Temporary Abutment is substantially equivalent to the original Hex-Lock® Temporary Abutment by design. They are substantially equivalent to the Friadent® EsthetiCap in that the materials and intended use are similar for both products. The Plastic Temporary Abutment is substantially equivalent to the PreFormance Post in that the body of the products are the same material as well as the intended use and period of use are equivalent.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with outstretched arms, representing care and protection. The figure is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in capital letters.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Mr. William Fisher Regulatory Affairs Associate Zimmer Dental, Incorporated 1900 Aston Avenue Carlsbad, California 92008-7308
NOV - 3 2009
Re: K092377
Trade/Device Name: Plastic Temporary Abutment Regulation Number: 21CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: August 3, 2009 Received: August 5, 2009
Dear Mr. Fisher:
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 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- Mr. Fisher
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 yours,
Susan Rumsey
Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) No. Zimmer Dental Plastic Temporary Abutment
No. K092377
A4 Page 1 of 1
Indications for Use
510(k) Number (if known):
Plastic Temporary Abutment Device Name:
Indications For Use:
The Plastic Temporary Abutment is intended to be used to fabricate and support provisional restorations that aid in creating an esthetic emergence through the gingiva during the healing period and prior to final restoration. The Plastic Temporary Abutment can be used for cementretained or screw-retained provisional restorations. The abutments can be used for single-unit and multi-unit restorations. Use of the Plastic Temporary Abutment is not to exceed onehundred and eighty (180) days.
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)
Keri Mulry for HSR
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K092377
Page 1 of 1
Page: Section A4-1