DENTAL SYRINGE SYSTEM-VARIOUS STYLES
FDA 510(k) clearance K832662 · decided 1983-10-04
Clearance details
- K-number
- K832662
- Device name
- DENTAL SYRINGE SYSTEM-VARIOUS STYLES
- Applicant
- Centrix, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-08-08
- Decision date
- 1983-10-04
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- KXR
- Device class
- 1
- Regulation number
- 872.3140
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BRUSH, APPLICATOR (K781098) | 3M Company | 1978-09-29 |
| CERAMIST BRUSH (K770160) | Deringer-Ney, Inc. | 1977-01-31 |
Recalls involving this device
No recalls on record reference this clearance.