UNITEK LIFT-OFF DEBRACKETING INSTRUMENT
FDA 510(k) clearance K854088 · decided 1985-11-26
Clearance details
- K-number
- K854088
- Device name
- UNITEK LIFT-OFF DEBRACKETING INSTRUMENT
- Applicant
- Unitex Corp.
- Decision
- Substantially Equivalent
- Date received
- 1985-10-07
- Decision date
- 1985-11-26
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- JEX
- Device class
- 1
- Regulation number
- 872.4565
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Monrovia, 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 |
|---|---|---|
| TITANIUM BIRD BEAK PLIER (K955242) | Sybron Dental Specialties, Inc. | 1995-12-01 |
| DENTAURUM PLIERS (K935141) | Dentauraum, Inc. | 1994-01-31 |
| TRANSCEND SERIES 6000 DEBONDING INSTRUMENTS (K924645) | Unitek Corp. | 1992-11-25 |
| DEBRACKETING INSTRUMENT (K924295) | Unitek Corp. | 1992-11-23 |
| UNITEK CONVERTIBLE CAP REMOVER TOOL (K843742) | Unitek Corp. | 1984-11-09 |
| ORTHODONTIC INSTRUMENTS (K760984) | Adp Intl., Inc. | 1976-11-15 |
Recalls involving this device
No recalls on record reference this clearance.