Various Dental Implants with Various Abutments
FDA 510(k) K981954 · Healthline Implants, Inc.
510(k) numberK981954
Submission
- Device name
- Various Dental Implants with Various Abutments
- Applicant
- Healthline Implants, Inc.
Marion, OH, US - Received
- June 4, 1998
- Decision date
- January 25, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- NRQ – Blade-Form Endosseous Dental Implant
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.3640
- Specialty
- Dental
- Implant
- Yes
Device made of a material such as titanium or titanium alloy, that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.
Other 510(k)s with product code NRQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K211872 | PiezoImplant SystemNRQ · Traditional | Rex Implants, Inc. | 10/12/2022SE |
| K822969 | Generation 5 Linkow Blade ImplantsNRQ · Traditional | Leonard P. Linkow, D.D.L. | 11/04/1982SE |
| K791366 | Oratronics Endosseous Frame AssemblyNRQ · Traditional | Oratronics, Inc. | 10/09/1979SE |
| K791204 | Miter Endosteal Blade ImplantNRQ · Traditional | Depuy, Inc. | 09/28/1979SE |
Questions and answers
When was Various Dental Implants with Various Abutments cleared by the FDA?
Various Dental Implants with Various Abutments (K981954) received a 510(k) decision of Substantially Equivalent on January 25, 1999, 235 days after the submission was received.
What is the product code of K981954?
The FDA product code is NRQ – Blade-Form Endosseous Dental Implant, a Class II (moderate risk) device regulated under 21 CFR 872.3640.