510(k) K791366
- Device
- ORATRONICS ENDOSSEOUS FRAME ASSEMBLY
- Applicant
- ORATRONICS, INC.
- 510(k) number
- K791366
- Product code
- NRQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1979-10-09
- Date received
- 1979-07-25
- Regulation
- 872.3640
- Classification name
- Blade-form Endosseous Dental Implant
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3014174860
- 3008870565
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code NRQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K211872 | PiezoImplant System | Rex Implants, Inc. | 2022-10-12 |
| K981954 | VARIOUS DENTAL IMPLANTS WITH VARIOUS ABUTMENTS | Healthline Implants, Inc. | 1999-01-25 |
| K822969 | GENERATION 5 LINKOW BLADE IMPLANTS | Leonard P. Linkow, D.D.L. | 1982-11-04 |
| K791204 | MITER ENDOSTEAL BLADE IMPLANT | Depuy, Inc. | 1979-09-28 |
Legacy Summary#
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FDA Review#
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