FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SOLO-TACH
K Number: K832292
·
Decision Sep 1, 1983
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
191
Applicant Total
279
Review Days
50
Basic Information
- Device Name
- SOLO-TACH
- K Number
- K832292
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3750
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- DENTSPLY INTL.
- Date Received
- July 13, 1983
- Decision Date
- September 1, 1983
- Product Code
- DYH
- 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 |
|---|---|---|---|
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DYH), ordered by most recent decision date.
Ormco EtchFree Bonding System, Ormco EtchFree Bonding Primer, Ormco EtchFree Adhesive
FDA 510(k)
FDA Class 2
·Dental
BracePaste Fluoride Sealant
FDA 510(k)
FDA Class 2
·Dental
3M Transbond Orthodontic Adhesive
FDA 510(k)
FDA Class 2
·Dental
AlignerFlow LC
FDA 510(k)
FDA Class 2
·Dental
TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520
FDA 510(k)
FDA Class 2
·Dental
FiteBac CC OrthoSeal
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by DENTSPLY INTL.
| K Number | Device Name | ||
|---|---|---|---|
| K123615 | IRIS - HIGH STRENGTH GLASS CERAMIC | Feb 22, 2013 | Substantially Equivalent |
| K072730 | FRIADENT CERCON AND ANKYLOS CERCON BALANCE ABUTMENTS | Mar 27, 2008 | Substantially Equivalent |
| K070538 | XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVE | Mar 14, 2007 | Substantially Equivalent |
| K070019 | CARRARA VOLUMIA | Jan 26, 2007 | Substantially Equivalent |
| K061427 | PRE-IMPRESSION CONDITIONING SOLUTION | Jun 26, 2006 | Substantially Equivalent |
| K052334 | CAVITRON RF ULTRASONIC SCALER SYSTEM WITH STERIMATE HANDPIECE, MODEL G-131 | Sep 2, 2005 | Substantially Equivalent |
| K051707 | ECLIPSE BONDING AGENT | Jul 15, 2005 | Substantially Equivalent |
| K051463 | XENO ADHESIVE WITH ACTIVATOR | Jul 12, 2005 | Substantially Equivalent |
| K051462 | MODIFICATION TO: CERCON BASE | Jun 24, 2005 | Substantially Equivalent |
| K050880 | DYRACT EXTRA RESTORATIVE | Apr 22, 2005 | Substantially Equivalent |