FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COMPOSITE/COMPOMER REPAIR KIT
K Number: K041960
·
Decision Aug 30, 2004
Classifications
1
FEI Numbers
137
Registration Numbers
137
Same Product Code
418
Applicant Total
28
Review Days
40
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
- COMPOSITE/COMPOMER REPAIR KIT
- K Number
- K041960
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 872.3200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dmg USA, Inc.
- Date Received
- July 21, 2004
- Decision Date
- August 30, 2004
- 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.
Any-Etch
FDA 510(k)
FDA Class 2
·Dental
Porcelain Etch Gel
FDA 510(k)
FDA Class 2
·Dental
Adhese 2
FDA 510(k)
FDA Class 2
·Dental
Bond-PR Universal Adhesive
FDA 510(k)
FDA Class 2
·Dental
VITA VMLC Primer
FDA 510(k)
FDA Class 2
·Dental
els unibond
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Dmg USA, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K171772 | Ecosite Bulk Fill | Jan 31, 2018 | Substantially Equivalent |
| K160443 | TempoCem Clear | Sep 30, 2016 | Substantially Equivalent |
| K130580 | RETRACTION PASTE | Feb 25, 2014 | Substantially Equivalent |
| K110759 | TEMPOCEM | Jun 10, 2011 | Substantially Equivalent |
| K102603 | SA FLOWABLE ADHESIVE | Nov 17, 2010 | Substantially Equivalent |
| K101710 | LUXATEMP ULTRA /STAR | Sep 28, 2010 | Substantially Equivalent |
| K100062 | INFILTRATION KIT | Mar 26, 2010 | Substantially Equivalent |
| K093338 | SELF ADHESIVE COMPOSITE LUTING CEMENT | Feb 12, 2010 | Substantially Equivalent |
| K093587 | DENTAL MERCURY | Jan 21, 2010 | Substantially Equivalent |
| K081493 | INFILTRATION KIT | Sep 18, 2008 | Substantially Equivalent |