FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REPLICA-F VISIBLE LIGHT-CURED ANT/POST DEN COM KIT
K Number: K861546
·
Decision May 21, 1986
Classifications
1
FEI Numbers
204
Registration Numbers
204
Same Product Code
931
Applicant Total
5
Review Days
26
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Basic Information
- Device Name
- REPLICA-F VISIBLE LIGHT-CURED ANT/POST DEN COM KIT
- K Number
- K861546
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3690
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Macrochem Corp.
- Date Received
- April 25, 1986
- Decision Date
- May 21, 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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Other Clearances by Macrochem Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K890608 | FLUOREVER(R) LIGHT CURE CERAMIC VENEER CEMENT | Apr 17, 1989 | Substantially Equivalent |
| K890623 | FLUOREVER(R) DUAL CURE CERAMIC VENEER CEMENT | Apr 17, 1989 | Substantially Equivalent |
| K890494 | FLUOREVER PIT AND FISSURE SEALANT OR FLUOREVER PFS | Mar 29, 1989 | Substantially Equivalent |
| K880562 | ADDITIONAL CLAIMS TO DENTAL RESTORATIVE COMP. KIT | Aug 19, 1988 | Substantially Equivalent for Some Indications |