FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NONSTAINING ALASTIKS
K Number: K910288
·
Decision Mar 29, 1991
Classifications
1
FEI Numbers
160
Registration Numbers
160
Same Product Code
102
Applicant Total
23
Review Days
66
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Basic Information
- Device Name
- NONSTAINING ALASTIKS
- K Number
- K910288
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.5410
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Unitek Corp.
- Date Received
- January 22, 1991
- Decision Date
- March 29, 1991
- Product Code
- EJF
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EJF | Bracket, Metal, Orthodontic | FDA class 1 | Dental |
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Other Clearances by Unitek Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K944286 | METAL-LINED TRANSCEND CERAMIC BRACKET | Nov 29, 1994 | Substantially Equivalent |
| K933501 | ALASTIK | Apr 28, 1994 | Substantially Equivalent |
| K940165 | ALASTIK | Mar 7, 1994 | Substantially Equivalent |
| K923999 | ALASTIK NS | Jun 24, 1993 | Substantially Equivalent |
| K924645 | TRANSCEND SERIES 6000 DEBONDING INSTRUMENTS | Nov 25, 1992 | Substantially Equivalent |
| K924295 | DEBRACKETING INSTRUMENT | Nov 23, 1992 | Substantially Equivalent |
| K923432 | GERMAN MINI DYNALOCK | Oct 30, 1992 | Substantially Equivalent |
| K911271 | ADHESIVE PRECOATED BRACKETS | May 29, 1991 | Substantially Equivalent |
| K890529 | ALASTIGARD | Mar 9, 1989 | Substantially Equivalent |
| K880392 | ORTHOLUX VISIBLE LIGHT CURING UNIT | Apr 7, 1988 | Substantially Equivalent |