FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KULZER GLAS-IONOMER CEMENT
K Number: K892453
·
Decision Dec 4, 1989
Classifications
1
FEI Numbers
144
Registration Numbers
144
Same Product Code
504
Applicant Total
31
Review Days
238
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Basic Information
- Device Name
- KULZER GLAS-IONOMER CEMENT
- K Number
- K892453
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3275
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Kulzer, Inc.
- Date Received
- April 10, 1989
- Decision Date
- December 4, 1989
- Product Code
- EMA
- 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 |
|---|---|---|---|
| EMA | Cement, Dental | FDA class 2 | Dental |
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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 |
| K903317 | DENTALON PLUS | Aug 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 |