FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ETCHANT 40%
K Number: K030743
·
Decision May 9, 2003
Classifications
1
FEI Numbers
133
Registration Numbers
133
Same Product Code
410
Applicant Total
31
Review Days
60
Basic Information
- Device Name
- ETCHANT 40%
- K Number
- K030743
- 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
- March 10, 2003
- Decision Date
- May 9, 2003
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KLE), ordered by most recent decision date.
HF-Etchant Hydrofluoric Acid Etching Gel
FDA 510(k)
FDA Class 2
·Dental
TopCEM Ceramic Primer Ceramic Coupling Agent
FDA 510(k)
FDA Class 2
·Dental
FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack)
FDA 510(k)
FDA Class 2
·Dental
Ceramic Etchant (HF-5 and HF-9)
FDA 510(k)
FDA Class 2
·Dental
K-Bond Universal
FDA 510(k)
FDA Class 2
·Dental
Light Cure Adhesive
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by CONFI-DENTAL PRODUCTS CO.
| K Number | Device Name | ||
|---|---|---|---|
| K030807 | CARIES INDICATOR | Jun 9, 2003 | Substantially Equivalent |
| K955329 | RESILIENCE M5 PROTECTION PLUS | Mar 28, 1996 | Substantially Equivalent |
| K955328 | CONFI-BOND | 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 |