FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SULTAN TOOTH ROOT DESENSITIZER
K Number: K072342
·
Decision Oct 3, 2007
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
137
Applicant Total
36
Review Days
43
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SULTAN TOOTH ROOT DESENSITIZER
- K Number
- K072342
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3260
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dentsply International, Inc.
- Date Received
- August 21, 2007
- Decision Date
- October 3, 2007
- Product Code
- LBH
- 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 |
|---|---|---|---|
| LBH | Varnish, Cavity | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LBH), ordered by most recent decision date.
Fluoride Varnish (Type A,Type C)
FDA 510(k)
FDA Class 2
·Dental
VOCO Profluorid Varnish + BioMin
FDA 510(k)
FDA Class 2
·Dental
UltraEZ
FDA 510(k)
FDA Class 2
·Dental
APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste)
FDA 510(k)
FDA Class 2
·Dental
FluoroDose Varnish
FDA 510(k)
FDA Class 2
·Dental
Rennou Varnish (3% / Spearmint); Rennou Varnish (3% / Strawberry); Rennou Varnish (3% / Cherry); Rennou Varnish (3% / Bubble Gum)
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Dentsply International, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K160207 | ATLANTIS ISUS Implant Suprastructures | Sep 21, 2016 | Substantially Equivalent |
| K160232 | Disposable Barrier Sleeves and Covers | Jun 7, 2016 | Substantially Equivalent |
| K151439 | ATLANTIS ISUS | Feb 19, 2016 | Substantially Equivalent |
| K152247 | ATLANTIS Crown | Jan 29, 2016 | Substantially Equivalent |
| K151039 | ATLANTIS Abutment for NobelActive 3.0 | Jan 14, 2016 | Substantially Equivalent |
| K151619 | Prime&Bond Elect Universal Dental Adhesive | Oct 30, 2015 | Substantially Equivalent |
| K150535 | Cavitron Touch Ultrasonic Scaling System | Jun 16, 2015 | Substantially Equivalent |
| K142178 | PROROOT MTA WHITE, PROROOT MTA GRAY | Feb 26, 2015 | Substantially Equivalent |
| K131907 | RAYPEX 6 | Jan 31, 2014 | Substantially Equivalent |
| K131644 | ANKYLOS SYNCONE ABUTMENT 5(DEGREE) | Jan 22, 2014 | Substantially Equivalent |