FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
OCCLUFAST
K Number: K935889
·
Decision Aug 23, 1994
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
401
Applicant Total
11
Review Days
315
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Basic Information
- Device Name
- OCCLUFAST
- K Number
- K935889
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Zhermack Dental Production
- Date Received
- October 12, 1993
- Decision Date
- August 23, 1994
- Product Code
- ELW
- 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 |
|---|---|---|---|
| ELW | Material, Impression | FDA class 2 | Dental |
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Other Clearances by Zhermack Dental Production
| K Number | Device Name | ||
|---|---|---|---|
| K935892 | INDURENT GEL | Oct 17, 1995 | Substantially Equivalent |
| K935890 | ZETAPLUS (PUTTY) | Sep 8, 1995 | Substantially Equivalent |
| K935898 | HYDROGUM | Aug 22, 1995 | Substantially Equivalent |
| K935896 | THIXOFLEX | Sep 9, 1994 | Substantially Equivalent |
| K935888 | ELITE FAST LIGHT BODY | Aug 23, 1994 | Substantially Equivalent |
| K935884 | ELITE PUTTY SOFT | Aug 23, 1994 | Substantially Equivalent |
| K931242 | ELITE PUTTY HARD | Aug 23, 1994 | Substantially Equivalent |
| K935885 | ELITE FAST PUTTY SOFT | Aug 23, 1994 | Substantially Equivalent |
| K935886 | ELITE LIGHT BODY | Aug 23, 1994 | Substantially Equivalent |
| K935887 | ELITE REGULAR BODY | Aug 23, 1994 | Substantially Equivalent |