Miter Endosteal Blade Implant
FDA 510(k) K791204 · Depuy, Inc.
510(k) numberK791204
Submission
- Device name
- Miter Endosteal Blade Implant
- Applicant
- Depuy, Inc.
Mchenry, IL, US - Received
- June 28, 1979
- Decision date
- September 28, 1979
- 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 |
| 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 |
More from Oratronics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K043058 | Pinnacle Constrained Acetabular LinersKWZ · Traditional | 03/14/2005SE |
| K042664 | LPS Upper ExtremityJDC · Traditional | 12/08/2004SE |
| K041085 | LPS (Limb Preservation System) Lower Extremity Dovetail IntercalaryJWH · Traditional | 07/22/2004SE |
| K033959 | LPSJWH · Traditional | 07/01/2004SE |
| K040544 | Duraloc Option Acetabular Cup System, Models 1599-01-044 to -066, 1599-11-044 to -062…LPH · Traditional | 05/28/2004SE |
| K021478 | Delta ShoulderPHX · Traditional | 11/18/2003SE |
| K033329 | Depuy Ace Universal and Troch Entry Femoral Nail SystemsHSB · Traditional | 11/14/2003SE |
| K032151 | Depuy Sigma Tibial Inserts and Co-Cr Tibial TraysJWH · Special | 09/26/2003SE |
| K020541 | Agility Ankle Revision ProsthesisHSN · Traditional | 05/20/2002SE |
| K011810 | Orthogenesis LPS Proximal Tibial Replacement and Orthogenesis LPS Tibial BearingKRO · Traditional | 09/07/2001SE |
Questions and answers
When was Miter Endosteal Blade Implant cleared by the FDA?
Miter Endosteal Blade Implant (K791204) received a 510(k) decision of Substantially Equivalent on September 28, 1979, 92 days after the submission was received.
What is the product code of K791204?
The FDA product code is NRQ – Blade-Form Endosseous Dental Implant, a Class II (moderate risk) device regulated under 21 CFR 872.3640.