FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
POLYCARBOXYLATE (PCA) CEMENT
K Number: K010240
·
Decision Mar 27, 2001
Classifications
1
FEI Numbers
144
Registration Numbers
144
Same Product Code
504
Applicant Total
7
Review Days
61
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Basic Information
- Device Name
- POLYCARBOXYLATE (PCA) CEMENT
- K Number
- K010240
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3275
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Rite-Dent Manufacturing Corp.
- Date Received
- January 25, 2001
- Decision Date
- March 27, 2001
- 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 |
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Other Clearances by Rite-Dent Manufacturing Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K020050 | ENAMEL BONDING SYSTEM | Feb 14, 2002 | Substantially Equivalent |
| K011822 | PIT AND FISSURE CHEMICAL CURING SEALANT | Aug 7, 2001 | Substantially Equivalent |
| K011453 | TOOTH SHADE RESIN MATERIAL | Jul 23, 2001 | Substantially Equivalent |
| K010255 | CAVITY VARNISH | Apr 20, 2001 | Substantially Equivalent |
| K003427 | ZINC PHOSPHATE CEMENT | Jan 24, 2001 | Substantially Equivalent |
| K003426 | ALGINATE IMPRESSION MATERIAL | Jan 23, 2001 | Substantially Equivalent |