FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENAMEL BONDING SYSTEM
K Number: K020050
·
Decision Feb 14, 2002
Classifications
1
FEI Numbers
137
Registration Numbers
137
Same Product Code
418
Applicant Total
7
Review Days
38
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Basic Information
- Device Name
- ENAMEL BONDING SYSTEM
- K Number
- K020050
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Rite-Dent Manufacturing Corp.
- Date Received
- January 7, 2002
- Decision Date
- February 14, 2002
- Product Code
- KLE
- 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 |
|---|---|---|---|
| KLE | Agent, Tooth Bonding, Resin | FDA class 2 | Dental |
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Other Clearances by Rite-Dent Manufacturing Corp.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K010240 | POLYCARBOXYLATE (PCA) CEMENT | Mar 27, 2001 | Substantially Equivalent |
| K003427 | ZINC PHOSPHATE CEMENT | Jan 24, 2001 | Substantially Equivalent |
| K003426 | ALGINATE IMPRESSION MATERIAL | Jan 23, 2001 | Substantially Equivalent |