FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CONFI-BOND
K Number: K955328
·
Decision Mar 28, 1996
Classifications
1
FEI Numbers
137
Registration Numbers
137
Same Product Code
418
Applicant Total
31
Review Days
129
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Basic Information
- Device Name
- CONFI-BOND
- K Number
- K955328
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Confi-Dental Products Co.
- Date Received
- November 20, 1995
- Decision Date
- March 28, 1996
- 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 Confi-Dental Products Co.
| K Number | Device Name | ||
|---|---|---|---|
| K030807 | CARIES INDICATOR | Jun 9, 2003 | Substantially Equivalent |
| K030743 | ETCHANT 40% | May 9, 2003 | Substantially Equivalent |
| K955329 | RESILIENCE M5 PROTECTION PLUS | Mar 28, 1996 | Substantially Equivalent |
| K954988 | CRYSTALLESSENCE | Mar 8, 1996 | Substantially Equivalent |
| K952930 | DENTRAY II PLUS TRAY ADHESIVE | Sep 8, 1995 | Substantially Equivalent |
| K946307 | CYRSTALLINE L3 MULTI-USE HYBRID COMPOSITE | Jan 26, 1995 | Substantially Equivalent |
| K940546 | GRANITEC IONOMER RESIN CEMENT | Apr 29, 1994 | Substantially Equivalent |
| K936070 | TREND SET 2 PLUS | Feb 4, 1994 | Substantially Equivalent |
| K935714 | CRYSTALLINE L3 MULTI-USE HYBRID COMPOSITE | Jan 21, 1994 | Substantially Equivalent |
| K933199 | CRYSTALLINE 'FLUORITE' CORE BUILD-UP MATERIAL | Jan 6, 1994 | Substantially Equivalent |