FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
S & C VINYL POLYSILOXANE IMPRESSION MATERIAL
K Number: K951075
·
Decision Mar 31, 1995
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
401
Applicant Total
20
Review Days
22
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Basic Information
- Device Name
- S & C VINYL POLYSILOXANE IMPRESSION MATERIAL
- K Number
- K951075
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- S & C Polymer GmbH
- Date Received
- March 9, 1995
- Decision Date
- March 31, 1995
- Product Code
- ELW
- 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 |
|---|---|---|---|
| ELW | Material, Impression | FDA class 2 | Dental |
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|---|---|---|---|
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| K082115 | PHOGLASS FILL, CORE, CEM, SEAL, PRIME AND PHOGLASS PROTECT | Jan 15, 2009 | Substantially Equivalent |
| K081702 | CARBOXYLATE CEM, PHOSPHATE CEM | Sep 5, 2008 | Substantially Equivalent |
| K042614 | S&C-SELF ETCH PR-BOND | Nov 22, 2004 | Substantially Equivalent |
| K031420 | S & C -BRACKET ADHESIVES | Aug 20, 2003 | Substantially Equivalent |
| K012767 | S & C HYDRO VINYL POLYSILOXANE IMPRESSION MATERIAL | Nov 1, 2001 | Substantially Equivalent |
| K011277 | HARD RELINER | Jun 26, 2001 | Substantially Equivalent |
| K011431 | RESIN CEM | Jun 11, 2001 | Substantially Equivalent |