FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DENTALON PLUS
K Number: K903317
·
Decision Aug 13, 1990
Classifications
1
FEI Numbers
180
Registration Numbers
180
Same Product Code
188
Applicant Total
31
Review Days
19
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
- DENTALON PLUS
- K Number
- K903317
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3770
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Kulzer, Inc.
- Date Received
- July 25, 1990
- Decision Date
- August 13, 1990
- 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 Kulzer, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K904928 | PALAVIT GLC | Jun 6, 1991 | Substantially Equivalent |
| K905058 | PALAVIT L | Jun 6, 1991 | Substantially Equivalent |
| K910263 | CHARISMA | Jun 3, 1991 | Substantially Equivalent |
| K910719 | SILICOATER MD | Apr 29, 1991 | Substantially Equivalent |
| K905131 | DURAFILL COLOR VS | Mar 15, 1991 | Substantially Equivalent |
| K905302 | DENTHESIVE | Feb 26, 1991 | Substantially Equivalent |
| K904555 | DURAFILL FLOW | Nov 13, 1990 | Substantially Equivalent |
| K902115 | PALAPRESS(R) VARIO RESIN | Jul 27, 1990 | Substantially Equivalent |
| K902350 | PALATRAY LC RESIN IMPRESSION TRAY MATERIAL | Jul 26, 1990 | Substantially Equivalent |
| K901789 | PALADON(R) 65 | Jun 22, 1990 | Substantially Equivalent |