Generation 5 Linkow Blade Implants
FDA 510(k) K822969 · Leonard P. Linkow, D.D.L.
510(k) numberK822969
Submission
- Device name
- Generation 5 Linkow Blade Implants
- Applicant
- Leonard P. Linkow, D.D.L.
Mchenry, IL, US - Received
- October 8, 1982
- Decision date
- November 4, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K981954 | Various Dental Implants with Various AbutmentsNRQ · Traditional | Healthline Implants, Inc. | 01/25/1999SE |
| 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 Generation 5 Linkow Blade Implants cleared by the FDA?
Generation 5 Linkow Blade Implants (K822969) received a 510(k) decision of Substantially Equivalent on November 4, 1982, 27 days after the submission was received.
What is the product code of K822969?
The FDA product code is NRQ – Blade-Form Endosseous Dental Implant, a Class II (moderate risk) device regulated under 21 CFR 872.3640.