DENTAURUM BRACKET POSITIONING GAUGE
FDA 510(k) clearance K935153 · decided 1994-01-31
Clearance details
- K-number
- K935153
- Device name
- DENTAURUM BRACKET POSITIONING GAUGE
- Applicant
- Dentauraum, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-10-28
- Decision date
- 1994-01-31
- Days to decision
- 95 days
- Clearance type
- Traditional
- Product code
- ECQ
- Device class
- 1
- Regulation number
- 872.4565
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Newtown, PA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Dentauraum
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| A-COMPANY STAINLESS STEEL ORTHODONTIC BRACKETS (K851454) | A Company, Inc. | 1985-04-29 |
Recalls involving this device
No recalls on record reference this clearance.