FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SOLARCRY/TEMPORARY CROWN & BRIDGE MAT
K Number: K831294
·
Decision Aug 31, 1983
Classifications
1
FEI Numbers
180
Registration Numbers
180
Same Product Code
188
Applicant Total
6
Review Days
133
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Basic Information
- Device Name
- SOLARCRY/TEMPORARY CROWN & BRIDGE MAT
- K Number
- K831294
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3770
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Solar Dental Co., Inc.
- Date Received
- April 20, 1983
- Decision Date
- August 31, 1983
- Product Code
- EBG
- 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 |
|---|---|---|---|
| EBG | Crown And Bridge, Temporary, Resin | FDA class 2 | Dental |
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Other Clearances by Solar Dental Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K871980 | D-23 DENTURE ADHESIVE | Jun 5, 1987 | Substantially Equivalent |
| K861846 | HYDRON ROOT CANAL FILLING & MARK IV STARTER KIT | Jun 26, 1986 | Substantially Equivalent |
| K852926 | DENTOLOCK II DENTURE ADHESIVE CREAM | Aug 23, 1985 | Substantially Equivalent |
| K831293 | SOLARCRYL CUSTOM TRAY MATERIAL | Jul 26, 1983 | Substantially Equivalent |
| K831265 | DENTOLOCK DENTURE ADHESIVE CREAM | May 9, 1983 | Substantially Equivalent |