FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HEATED GUTTA PERCHA DELIVERY SYSTEM
K Number: K832654
·
Decision Sep 26, 1983
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
22
Applicant Total
23
Review Days
49
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Basic Information
- Device Name
- HEATED GUTTA PERCHA DELIVERY SYSTEM
- K Number
- K832654
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.3850
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Unitek Corp.
- Date Received
- August 8, 1983
- Decision Date
- September 26, 1983
- Product Code
- EKM
- 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 |
|---|---|---|---|
| EKM | Gutta-Percha | 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 |
| K910288 | NONSTAINING ALASTIKS | Mar 29, 1991 | Substantially Equivalent |
| K890529 | ALASTIGARD | Mar 9, 1989 | Substantially Equivalent |