LC TRAY MATERIAL
FDA 510(k) clearance K923979 · decided 1992-11-17
Clearance details
- K-number
- K923979
- Device name
- LC TRAY MATERIAL
- Applicant
- Dentsply Intl.
- Decision
- Substantially Equivalent
- Date received
- 1992-08-06
- Decision date
- 1992-11-17
- Days to decision
- 103 days
- Clearance type
- Traditional
- Product code
- EBH
- Device class
- 1
- Regulation number
- 872.3670
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- York, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PERMAGEN UNIVERSAL BONDING RESIN (K933745) | Bio-Systems Research | 1994-01-26 |
| PALATRAY LC MINT (K930487) | Heraeus Kulzer, Inc. | 1993-06-18 |
| PALADISC LC (K923549) | Heraeus Kulzer, Inc. | 1992-09-29 |
| POLYESTER RESIN HAND MOLDED TRAY (K912820) | E&D Dental Products, Inc. | 1991-08-21 |
| PALAVIT L (K905058) | Kulzer, Inc. | 1991-06-06 |
| PALATRAY LC RESIN IMPRESSION TRAY MATERIAL (K902350) | Kulzer, Inc. | 1990-07-26 |
| CONVERTRAY CUSTOM IMPRESSION TRAY MATERIAL SYSTEM (K901782) | Productivity Training Corp. | 1990-06-29 |
| ADVANTAGE DENTAL CUST DENT IMPRESS/BASEPLATE TRAYS (K890712) | Advantage Dental Products, Inc. | 1989-04-25 |
| MODIFIED PERMAGUM ADHESIVE (K881838) | Espe GmbH (Us) | 1988-07-27 |
| IMPREGUM F ADHESIVE (K875257) | Espe GmbH (Us) | 1988-03-09 |
| PERMADYNE ADHESIVE (K875228) | Espe GmbH (Us) | 1988-03-09 |
| ACRYLIC IMPRESSION TRAY MATERIALS (K873739) | E&D Dental Manufacturing Co. | 1988-03-07 |
Recalls involving this device
No recalls on record reference this clearance.