FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
PHOGLASS FILL, CORE, CEM, SEAL, PRIME AND PHOGLASS PROTECT
K Number: K082115
·
Decision Jan 15, 2009
Classifications
1
FEI Numbers
142
Registration Numbers
142
Same Product Code
495
Applicant Total
20
Review Days
171
Basic Information
- Device Name
- PHOGLASS FILL, CORE, CEM, SEAL, PRIME AND PHOGLASS PROTECT
- K Number
- K082115
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3275
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- S & C POLYMER GMBH
- Date Received
- July 28, 2008
- Decision Date
- January 15, 2009
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EMA), ordered by most recent decision date.
Choice 2 DC
FDA 510(k)
FDA Class 2
·Dental
ResiCem EX
FDA 510(k)
FDA Class 2
·Dental
EsCem RMGI
FDA 510(k)
FDA Class 2
·Dental
OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment
FDA 510(k)
FDA Class 2
·Dental
Insure® Universal; Insure® Universal Automix
FDA 510(k)
FDA Class 2
·Dental
TopCEM-Veneer Light Cure Veneer Cement
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by S & C POLYMER GMBH
| K Number | Device Name | ||
|---|---|---|---|
| K091735 | DC PROVI CEM ESTHETIC, ESTHETIC MULTI F, IMPLANT | Sep 25, 2009 | Substantially Equivalent |
| K083062 | ROOT CANAL XR | Mar 12, 2009 | Substantially Equivalent |
| K083766 | PHOGLASS CEM | Mar 2, 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 |
| K011064 | CLASSIC CEM | May 17, 2001 | Substantially Equivalent |