FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
ROOT CANAL XR
K Number: K083062
·
Decision Mar 12, 2009
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
142
Applicant Total
20
Review Days
149
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Basic Information
- Device Name
- ROOT CANAL XR
- K Number
- K083062
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3820
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- S & C Polymer GmbH
- Date Received
- October 14, 2008
- Decision Date
- March 12, 2009
- Product Code
- KIF
- 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 |
|---|---|---|---|
| KIF | Resin, Root Canal Filling | FDA class 2 | Dental |
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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 |
| K083766 | PHOGLASS CEM | Mar 2, 2009 | Substantially Equivalent |
| 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 |
| K011064 | CLASSIC CEM | May 17, 2001 | Substantially Equivalent |