DENTAURUM SPACE MAINTAINER
FDA 510(k) clearance K935856 · decided 1994-04-28
Clearance details
- K-number
- K935856
- Device name
- DENTAURUM SPACE MAINTAINER
- Applicant
- Dentauraum, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-12-08
- Decision date
- 1994-04-28
- Days to decision
- 141 days
- Clearance type
- Traditional
- Product code
- DYT
- Device class
- 1
- Regulation number
- 872.5525
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Newtown, PA, 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 |
|---|---|---|
| FIBERBOND (K864376) | Dentec, Inc. | 1987-04-07 |
| UNITEK PALATAL BAR (K812239) | Unitek Corp. | 1981-09-21 |
| SAFETY STOP NECKSTRAP (K780814) | Northwest Orthodontics, Inc. | 1978-06-30 |
Recalls involving this device
No recalls on record reference this clearance.