FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
4-IN-1 DISP. CROWN & BRIDGE TRAY
K Number: K780211
·
Decision Feb 16, 1978
Classifications
1
FEI Numbers
317
Registration Numbers
317
Same Product Code
15
Applicant Total
32
Review Days
8
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Basic Information
- Device Name
- 4-IN-1 DISP. CROWN & BRIDGE TRAY
- K Number
- K780211
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6880
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Kerr Corporation (Danbury)
- Date Received
- February 8, 1978
- Decision Date
- February 16, 1978
- Product Code
- EHY
- 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 |
|---|---|---|---|
| EHY | Tray, Impression, Preformed | FDA class 1 | Dental |
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PREFORMED DENTAL IMPRESSION TRAYS
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CROWN INDEX TRAY
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| K951511 | TYTIN ADMIX | May 2, 1995 | Substantially Equivalent |
| K942480 | M4 CONTRA-ANGLE HANDPIECE | Jan 27, 1995 | Substantially Equivalent |
| K940513 | OPTIBOND | Apr 15, 1994 | Substantially Equivalent |
| K935535 | TYTIN | Mar 11, 1994 | Substantially Equivalent |
| K934690 | KERR OPTIBOND, MODIFICATION | Dec 30, 1993 | Substantially Equivalent |
| K923546 | OPTIBOND | Sep 29, 1992 | Substantially Equivalent |
| K915847 | AUTOMIX DENTAL AMALGAMATOR | Mar 2, 1992 | Substantially Equivalent |