FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ONE COAT BOND DENTIN/ENAMEL ADHESIVE SYSTEM
K Number: K974906
·
Decision Mar 24, 1998
Classifications
1
FEI Numbers
137
Registration Numbers
137
Same Product Code
418
Applicant Total
21
Review Days
83
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Basic Information
- Device Name
- ONE COAT BOND DENTIN/ENAMEL ADHESIVE SYSTEM
- K Number
- K974906
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Coltene/Whaledent, Inc.
- Date Received
- December 31, 1997
- Decision Date
- March 24, 1998
- 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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|---|---|---|---|
| K071632 | PERFECT TISSUE CONTOURING SYSTEM II | Oct 18, 2007 | Substantially Equivalent |
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| K040551 | COLTOLUX LED CURING LIGHT | Mar 15, 2004 | Substantially Equivalent |
| K033760 | ONE COAT SE BOND | Jan 23, 2004 | Substantially Equivalent |
| K031752 | COLTOSOL F | Aug 5, 2003 | Substantially Equivalent |
| K013400 | SYNERGY FLOW | Dec 10, 2001 | Substantially Equivalent |
| K003034 | COLTENE AURA COMPOMER RESTORATIVE SYSTEM | Nov 30, 2000 | Substantially Equivalent |
| K993545 | TENAX WHITE POST | Apr 14, 2000 | Substantially Equivalent |
| K000311 | PARAPOST FIBER WHITE | Mar 14, 2000 | Substantially Equivalent |
| K993710 | MODIFICATION OF PARAPOST CEMENT | Dec 21, 1999 | Substantially Equivalent |