FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CEMENT, DENTAL/CAVITY LINER
K Number: K781281
·
Decision Aug 21, 1978
Classifications
1
FEI Numbers
144
Registration Numbers
144
Same Product Code
504
Applicant Total
5
Review Days
26
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Basic Information
- Device Name
- CEMENT, DENTAL/CAVITY LINER
- K Number
- K781281
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3275
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Star Dental Mfg. Co.
- Date Received
- July 26, 1978
- Decision Date
- August 21, 1978
- Product Code
- EMA
- 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 |
|---|---|---|---|
| EMA | Cement, Dental | FDA class 2 | Dental |
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Other Clearances by Star Dental Mfg. Co.
| K Number | Device Name | ||
|---|---|---|---|
| K905155 | HIGH SPEED CEREAMIC BEARING TURBINE HANDPIECES | Feb 13, 1991 | Substantially Equivalent |
| K782007 | ROTARY SCALER | Jan 3, 1979 | Substantially Equivalent |
| K771247 | CORE MATERIAL | Jul 15, 1977 | Substantially Equivalent |
| K771246 | ALARM SYS FOR NITROUS OXIDE SYS. | Jul 15, 1977 | Substantially Equivalent |