HAWLEY RETAINER ORTHODONTIC APPLICANCE KIT
FDA 510(k) clearance K943334 · decided 1994-10-05
Clearance details
- K-number
- K943334
- Device name
- HAWLEY RETAINER ORTHODONTIC APPLICANCE KIT
- Applicant
- Jay H. Geller
- Decision
- Substantially Equivalent
- Date received
- 1994-07-12
- Decision date
- 1994-10-05
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- DZC
- Device class
- 1
- Regulation number
- 872.5410
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Santa Monica, CA, 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 |
|---|---|---|
| HYPERELASTIC WIRE (K112640) | Ormco Corp. | 2011-11-16 |
| NITINOL, NITI (K935638) | Highland Metals | 1994-05-18 |
| DENTAURUM STEEL LIGATURE WIRES (K935140) | Dentauraum, Inc. | 1994-02-04 |
| DENTAURUM WIRES (K935142) | Dentauraum, Inc. | 1994-01-31 |
| FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIRE (K934265) | Flexmedics | 1994-01-21 |
| NITI COIL SPRINGS (K933374) | Highland Metals | 1993-11-19 |
| STAINLESS STEEL ARCHES REPACKER RELABETER (K933377) | Highland Metals | 1993-11-16 |
| REVERSE CURVE NITI ARCH WIRE REPACKER RELABETER (K933378) | Highland Metals | 1993-11-12 |
| REVERSE SURVE NITI ARCH WIRE (K933380) | Highland Metals | 1993-11-12 |
| STAINLESS STEEL ARCHES (K933379) | Highland Metals | 1993-11-12 |
| NITI ARCH WIRE ON A SPOOL (K933376) | Highland Metals | 1993-11-12 |
| COATED ORTHODONTIC DEVICES (K931631) | Wonder Wire | 1993-07-28 |
Recalls involving this device
No recalls on record reference this clearance.