FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DEN-MAT DENTIN LINK
K Number: K862449
·
Decision Jul 22, 1986
Classifications
1
FEI Numbers
204
Registration Numbers
204
Same Product Code
931
Applicant Total
29
Review Days
25
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Basic Information
- Device Name
- DEN-MAT DENTIN LINK
- K Number
- K862449
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3690
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Den-Mat Corp.
- Date Received
- June 27, 1986
- Decision Date
- July 22, 1986
- Product Code
- EBF
- 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 |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | FDA class 2 | Dental |
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| K864346 | REMBRANDT PORCELAIN TINTING KIT | Jan 7, 1987 | 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 |