FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
USI DENTAL POLISHER. A/G-20
K Number: K873147
·
Decision Oct 14, 1987
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
24
Applicant Total
2
Review Days
64
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
- USI DENTAL POLISHER. A/G-20
- K Number
- K873147
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Cranston Ind., Inc.
- Date Received
- August 11, 1987
- Decision Date
- October 14, 1987
- Product Code
- EFA
- 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 |
|---|---|---|---|
| EFA | Handpiece, Belt And/Or Gear Driven, Dental | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EFA), ordered by most recent decision date.
Dental Handpiece
FDA 510(k)
FDA Class 1
·Dental
SMARTmatic
FDA 510(k)
FDA Class 1
·Dental
MASTERmatic LUX
FDA 510(k)
FDA Class 1
·Dental
RDT3 HANDPIECE HEAD MODEL RDT3
FDA 510(k)
FDA Class 1
·Dental
ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLE
FDA 510(k)
FDA Class 1
·Dental
INTRA LUX HEAD 3 LDSY
FDA 510(k)
FDA Class 1
·Dental
Other Clearances by Cranston Ind., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K873146 | USI BASIC. AG 1050. AG 1090 | Oct 27, 1987 | Substantially Equivalent |