FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MULTIPLE (TOOTH DESENSITIZER)
K Number: K052263
·
Decision Dec 16, 2005
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
137
Applicant Total
28
Review Days
119
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
- MULTIPLE (TOOTH DESENSITIZER)
- K Number
- K052263
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3260
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cosmedent, Inc.
- Date Received
- August 19, 2005
- Decision Date
- December 16, 2005
- 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 Cosmedent, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K240714 | Insure® Universal; Insure® Universal Automix | Jul 24, 2024 | Substantially Equivalent |
| K222435 | Renamel® Microhybrid ;Renamel® Flowable Microhybrid | Oct 11, 2022 | Substantially Equivalent |
| K211259 | Renamel Bulkfill | Jun 24, 2021 | Substantially Equivalent |
| K172707 | Renamel Microfill | Dec 5, 2017 | Substantially Equivalent |
| K163480 | Renamel NANO +plus | Feb 24, 2017 | Substantially Equivalent |
| K092730 | COSMEDENT BRUSHABLE COMPOSITE | Nov 20, 2009 | Substantially Equivalent |
| K070583 | NANO COMPOSITE | Apr 16, 2007 | Substantially Equivalent |
| K060881 | TEMPORARY CROWN & BRIDGE RESIN | May 16, 2006 | Substantially Equivalent |
| K052501 | MULTIPLE RESIN TOOTH BONDING AGENT | Oct 21, 2005 | Substantially Equivalent |
| K042823 | COSMEDENT PIT & FISSURE SEALANT | Dec 1, 2004 | Substantially Equivalent |