FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HANDPIECE, LIFT, ENDO
K Number: K780213
·
Decision Feb 17, 1978
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
72
Applicant Total
32
Review Days
9
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Basic Information
- Device Name
- HANDPIECE, LIFT, ENDO
- K Number
- K780213
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Kerr Corporation (Danbury)
- Date Received
- February 8, 1978
- Decision Date
- February 17, 1978
- Product Code
- EGS
- 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 |
|---|---|---|---|
| EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | FDA class 1 | Dental |
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| K951663 | TYTIN R | Jun 6, 1995 | Substantially Equivalent |
| 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 |