FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PALATRAY LC RESIN IMPRESSION TRAY MATERIAL
K Number: K902350
·
Decision Jul 26, 1990
Classifications
1
FEI Numbers
187
Registration Numbers
187
Same Product Code
29
Applicant Total
31
Review Days
62
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Basic Information
- Device Name
- PALATRAY LC RESIN IMPRESSION TRAY MATERIAL
- K Number
- K902350
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.3670
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Kulzer, Inc.
- Date Received
- May 25, 1990
- Decision Date
- July 26, 1990
- Product Code
- EBH
- 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 |
|---|---|---|---|
| EBH | Material, Impression Tray, Resin | FDA class 1 | 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 |
| K901789 | PALADON(R) 65 | Jun 22, 1990 | Substantially Equivalent |