FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CORE MATERIAL
K Number: K771247
·
Decision Jul 15, 1977
Classifications
1
FEI Numbers
204
Registration Numbers
204
Same Product Code
931
Applicant Total
5
Review Days
4
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- CORE MATERIAL
- K Number
- K771247
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3690
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Star Dental Mfg. Co.
- Date Received
- July 11, 1977
- Decision Date
- July 15, 1977
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EBF), ordered by most recent decision date.
SRGC-06
FDA 510(k)
FDA Class 2
·Dental
DIAFIL
FDA 510(k)
FDA Class 2
·Dental
DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)
FDA 510(k)
FDA Class 2
·Dental
Dual Core
FDA 510(k)
FDA Class 2
·Dental
Dura-Crown
FDA 510(k)
FDA Class 2
·Dental
Grandio disc multicolor
FDA 510(k)
FDA Class 2
·Dental
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 |
| K781281 | CEMENT, DENTAL/CAVITY LINER | Aug 21, 1978 | Substantially Equivalent |
| K771246 | ALARM SYS FOR NITROUS OXIDE SYS. | Jul 15, 1977 | Substantially Equivalent |