FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DW 236
K Number: K905204
·
Decision Mar 29, 1991
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
73
Applicant Total
131
Review Days
129
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
- DW 236
- K Number
- K905204
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3070
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Ivoclar North America, Inc.
- Date Received
- November 20, 1990
- Decision Date
- March 29, 1991
- Product Code
- EJJ
- 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 |
|---|---|---|---|
| EJJ | Alloy, Amalgam | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EJJ), ordered by most recent decision date.
SILVERFIL
FDA 510(k)
FDA Class 2
·Dental
SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70
FDA 510(k)
FDA Class 2
·Dental
BESTALOY
FDA 510(k)
FDA Class 2
·Dental
BENCO ADMIX
FDA 510(k)
FDA Class 2
·Dental
BENCO SPHERICAL
FDA 510(k)
FDA Class 2
·Dental
HIGH SILVER CONVENTIONAL
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Ivoclar North America, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K012174 | ERIS LAYERING MATERIALS | Aug 27, 2001 | Substantially Equivalent |
| K011491 | HELIOSEAL CLEAR CHROMA | Aug 16, 2001 | Substantially Equivalent |
| K011492 | IN TEN-S | Jul 5, 2001 | Substantially Equivalent |
| K011490 | MODIFICATION TO EXCITE | Jun 27, 2001 | Substantially Equivalent |
| K011023 | D.SIGN 96 | May 2, 2001 | Substantially Equivalent |
| K011022 | BIOUNIVERSAL PDF | May 2, 2001 | Substantially Equivalent |
| K010381 | D.SIGN 30 | Mar 6, 2001 | Substantially Equivalent |
| K010250 | TETRIC CERAM HB | Feb 28, 2001 | Substantially Equivalent |
| K003293 | EXCITE DSC | Feb 6, 2001 | Substantially Equivalent |
| K003407 | SYSTEMP.DESENSITIZER (VIVADENT.DESENSITIZER) | Jan 26, 2001 | Substantially Equivalent |