FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INFILTRATION KIT
K Number: K081493
·
Decision Sep 18, 2008
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
130
Applicant Total
28
Review Days
113
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
- INFILTRATION KIT
- K Number
- K081493
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 872.3765
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dmg USA, Inc.
- Date Received
- May 28, 2008
- Decision Date
- September 18, 2008
- Product Code
- EBC
- 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 |
|---|---|---|---|
| EBC | Sealant, Pit And Fissure, And Conditioner | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EBC), ordered by most recent decision date.
Any-Com Seal
FDA 510(k)
FDA Class 2
·Dental
Parkell Pit and Fissure Sealant
FDA 510(k)
FDA Class 2
·Dental
UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio
FDA 510(k)
FDA Class 2
·Dental
Enamel Coating Resin
FDA 510(k)
FDA Class 2
·Dental
BA Pit & Fissure Sealant
FDA 510(k)
FDA Class 2
·Dental
Helioseal F Plus
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 |
| K080480 | NANOCOMPOSITE RESTORATIVE KIT | May 30, 2008 | Substantially Equivalent |