510(k) K771176
- Device
- GOTHIC ARCH TRACING
- Applicant
- Dentsply Intl.
- 510(k) number
- K771176
- Product code
- KZO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-08-16
- Date received
- 1977-06-30
- Regulation
- 872.3150
- Classification name
- Ink, Arch Tracing
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 9612352
- 3009496224
- 1000493628
- 3013846070
- 3009171220
- 3004966444
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KZO#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K810972 | THE GNATHOMETER-M | Bauer, Cheng & Associates, Inc. | 1981-05-05 |