FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NIMETIC POLISHING PASTE
K Number: K771852
·
Decision Nov 2, 1977
Classifications
1
FEI Numbers
142
Registration Numbers
142
Same Product Code
76
Applicant Total
59
Review Days
34
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Basic Information
- Device Name
- NIMETIC POLISHING PASTE
- K Number
- K771852
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6030
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Espe GmbH (Us)
- Date Received
- September 29, 1977
- Decision Date
- November 2, 1977
- Product Code
- EJR
- 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 |
|---|---|---|---|
| EJR | Agent, Polishing, Abrasive, Oral Cavity | FDA class 1 | Dental |
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Other Clearances by Espe GmbH (Us)
| K Number | Device Name | ||
|---|---|---|---|
| K925027 | PHOTAC-FIL APLICAP | Jun 18, 1993 | Substantially Equivalent |
| K915005 | PHOTAC-BOND APLICAP, MODIFICATION | Jan 14, 1992 | Substantially Equivalent |
| K913966 | SONO(R) -CEM | Jan 14, 1992 | Substantially Equivalent |
| K913857 | ROCATEC(R) -PLUS | Dec 16, 1991 | Substantially Equivalent |
| K913965 | ESPE(R) -SIL | Dec 4, 1991 | Substantially Equivalent |
| K905604 | VISIO-GEM ART-SYSTEM | Mar 29, 1991 | Substantially Equivalent |
| K904096 | PHOTAC-BOND | Nov 19, 1990 | Substantially Equivalent |
| K904097 | PHOTAC-BOND APLICAP | Nov 9, 1990 | Substantially Equivalent |
| K904289 | PERTAC UNIVERSAL BOND | Nov 1, 1990 | Substantially Equivalent |
| K900510 | PERTAC-HYBRID | Aug 9, 1990 | Substantially Equivalent |