ALASTIK
FDA 510(k) clearance K933501 · decided 1994-04-28
Clearance details
- K-number
- K933501
- Device name
- ALASTIK
- Applicant
- Unitek Corp.
- Decision
- Substantially Equivalent
- Date received
- 1993-07-19
- Decision date
- 1994-04-28
- Days to decision
- 283 days
- Clearance type
- Traditional
- Product code
- EJF
- Device class
- 1
- Regulation number
- 872.5410
- 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 |
|---|---|---|
| BITEM LOCK, MODELS SW006, SW012 (K994357) | Thermoelastic Technologies, Inc. | 2000-03-14 |
| MICROARCH GOLD BRACKET (K932825) | Gac Intl., Inc. | 1994-05-09 |
| MEMORY WIRE (K923372) | Althan, Inc. | 1994-04-22 |
| ORTHOTECH DURA-GOLD BARCKETS (K933080) | Orthotech | 1994-03-23 |
| FASCINATION CERAMIC BRACKET (K935139) | Dentauraum, Inc. | 1994-02-04 |
| REGENCY BRACKET (K936244) | Mid-American Dental Specialties, Inc. | 1994-02-02 |
| REFLECTIONS (K934881) | Cdb Corp. | 1994-02-01 |
| DENTAURUM METAL BRACKETS (K935122) | Dentauraum, Inc. | 1994-01-31 |
| FORESTADENT ORTHODONTIC BANDS (K925028) | Forestadent | 1994-01-26 |
| LARIAT PALATE EXPANDER (K926427) | Easy Access Orthodontics, Inc. | 1994-01-26 |
| CHANNEL-EDGE BRACKET SYSTEM (K930881) | Dualtek, Inc. | 1994-01-21 |
| REGENCY PLUS BRACKET (K933758) | Mid-American Dental Specialties, Inc. | 1994-01-18 |
Recalls involving this device
No recalls on record reference this clearance.