FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EVADYNE TEMPORARY CROWN AND BRIDGE RESIN
K Number: K111666
·
Decision Sep 7, 2011
Classifications
1
FEI Numbers
180
Registration Numbers
180
Same Product Code
188
Applicant Total
5
Review Days
85
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Basic Information
- Device Name
- EVADYNE TEMPORARY CROWN AND BRIDGE RESIN
- K Number
- K111666
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3770
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Neodental Chemical Products Co., Ltd.
- Date Received
- June 14, 2011
- Decision Date
- September 7, 2011
- Product Code
- EBG
- 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 |
|---|---|---|---|
| EBG | Crown And Bridge, Temporary, Resin | FDA class 2 | Dental |
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Other Clearances by Neodental Chemical Products Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K111668 | CAVIOS CAVITY LINER | Aug 19, 2011 | Substantially Equivalent |
| K973667 | VITAPEX PRE-LOADED DENTAL SYRINGE | Nov 6, 1997 | Substantially Equivalent |
| K971642 | DENTALIS KEZ ENDODONITC SEALER | Jul 24, 1997 | Substantially Equivalent |
| K955703 | NEO DENTAL ENDODONTIC IRRIGATION SYRINGE | May 20, 1996 | Substantially Equivalent |