FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BELLEGLASS HP MODELING GEL
K Number: K020178
·
Decision Mar 15, 2002
Classifications
1
FEI Numbers
180
Registration Numbers
180
Same Product Code
188
Applicant Total
17
Review Days
56
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
- BELLEGLASS HP MODELING GEL
- K Number
- K020178
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3770
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kerr Dental Materials Center
- Date Received
- January 18, 2002
- Decision Date
- March 15, 2002
- Product Code
- EBG
- 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 |
|---|---|---|---|
| EBG | Crown And Bridge, Temporary, Resin | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EBG), ordered by most recent decision date.
Dura-Arch
FDA 510(k)
FDA Class 2
·Dental
FLNT Base and FLNT Temp
FDA 510(k)
FDA Class 2
·Dental
TempFIT Temporary Crown and Bridge Resin
FDA 510(k)
FDA Class 2
·Dental
DentaTOOTH
FDA 510(k)
FDA Class 2
·Dental
Evoblock, Perléon
FDA 510(k)
FDA Class 2
·Dental
TEMP MASTER, PMMA-based dental resin
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Kerr Dental Materials Center
| K Number | Device Name | ||
|---|---|---|---|
| K050984 | BIOPLANT | Aug 11, 2005 | Substantially Equivalent |
| K031444 | OPTIBOND FL | Jul 2, 2003 | Substantially Equivalent |
| K030646 | BELLEGLASS POINT 4 | May 6, 2003 | Substantially Equivalent |
| K020303 | XR PRIMER 2 | Apr 19, 2002 | Substantially Equivalent |
| K014027 | OPTIBOND SOLO PLUS 4 | Feb 22, 2002 | Substantially Equivalent |
| K020092 | TEMPHASE | Feb 22, 2002 | Substantially Equivalent |
| K013375 | BELLEGLASS HP OPAQUE 2 | Oct 29, 2001 | Substantially Equivalent |
| K013325 | POINT 4 FLOWABLE 2 | Oct 23, 2001 | Substantially Equivalent |
| K011908 | OPTIBOND SOLO PLUS 3 | Sep 6, 2001 | Substantially Equivalent |
| K000357 | EZ CONNECT RESIN | Apr 28, 2000 | Substantially Equivalent |