FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
1ST IMPRESSION
K Number: K983106
·
Decision Feb 9, 1999
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
401
Applicant Total
29
Review Days
158
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Basic Information
- Device Name
- 1ST IMPRESSION
- K Number
- K983106
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Den-Mat Corp.
- Date Received
- September 4, 1998
- Decision Date
- February 9, 1999
- 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 Den-Mat Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K895731 | DEN-MAT CERINATE PORCELAIN | Aug 3, 1990 | Substantially Equivalent |
| K895269 | DEN-MAT LAMI-QUICK | Feb 22, 1990 | Substantially Equivalent |
| K881918 | LIGHT-CURED ZIONOMER CEMENT | Jul 15, 1988 | Substantially Equivalent |
| K875351 | DEN-MAT PORETCH (PORCELAIN ETCHANT) | Mar 18, 1988 | Substantially Equivalent |
| K872510 | DEN-MAT TENURE | Aug 24, 1987 | Substantially Equivalent |
| K870130 | DEN-MAT SECURE ANTI-ROTATIONAL POST-CORE SYSTEM | Feb 19, 1987 | Substantially Equivalent |
| K864346 | REMBRANDT PORCELAIN TINTING KIT | Jan 7, 1987 | Substantially Equivalent |
| K862449 | DEN-MAT DENTIN LINK | Jul 22, 1986 | Substantially Equivalent |
| K860971 | DEN-MAT GOLD LINK (FORMERLY DEN-MAT METAL OPAQUER) | Mar 25, 1986 | Substantially Equivalent |
| K852630 | DEN-MAT PAINT-ON RUBBER DAM | Dec 18, 1985 | Substantially Equivalent |