FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Nobilplast Denture Resin
K Number: K170375
·
Decision Oct 2, 2017
Classifications
1
FEI Numbers
166
Registration Numbers
166
Same Product Code
329
Applicant Total
7
Review Days
237
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Basic Information
- Device Name
- Nobilplast Denture Resin
- K Number
- K170375
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3760
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cmp Industries, LLC
- Date Received
- February 7, 2017
- Decision Date
- October 2, 2017
- Product Code
- EBI
- 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 |
|---|---|---|---|
| EBI | Resin, Denture, Relining, Repairing, Rebasing | FDA class 2 | Dental |
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Other Clearances by Cmp Industries, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K170423 | DentureID Microchip | Oct 25, 2017 | Substantially Equivalent |
| K072851 | POLYSTAR 79 DENTURE BASE RESIN | Feb 20, 2008 | Substantially Equivalent |
| K072402 | FLEX-STAR V | Oct 19, 2007 | Substantially Equivalent |
| K033020 | IMPAK ACRYLIC REPAIR RESIN LIQUID | Dec 19, 2003 | Substantially Equivalent |
| K953594 | VULCAN | Sep 5, 1995 | Substantially Equivalent |
| K902972 | FLEXOR (DENTURE ACRYLIC RELINE MATERIAL) | Oct 4, 1990 | Substantially Equivalent |