EBH · Material, Impression Tray, Resin
Dental · 21 CFR 872.3670 · Class 1
Overview
| Product Code | EBH |
|---|---|
| Device Name | Material, Impression Tray, Resin |
| Regulation | 21 CFR 872.3670 |
| Device Class | Class 1 |
| Review Panel | Dental |
| GMP Exempt | Yes |
Identification
Resin impression tray material is a device intended for use in a two-step dental mold fabricating process. The device consists of a resin material, such as methyl methacrylate, and is used to form a custom impression tray for use in cases in which a preformed impression tray is not suitable, such as the fabrication of crowns, bridges, or full dentures. A preliminary plaster or stone model of the patient's teeth and gums is made. The resin impression tray material is applied to this preliminary study model to form a custom tray. This tray is then filled with impression material and inserted into the patient's mouth to make an impression, from which a final, more precise, model of the patient's mouth is cast.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (20 of 30)
Showing 20 most recent of 30 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K933745 | PERMAGEN UNIVERSAL BONDING RESIN | Bio-Systems Research | Jan 26, 1994 | SESE |
| K930487 | PALATRAY LC MINT | Heraeus Kulzer, Inc. | Jun 18, 1993 | SESE |
| K923979 | LC TRAY MATERIAL | Dentsply Intl. | Nov 17, 1992 | SESE |
| K923549 | PALADISC LC | Heraeus Kulzer, Inc. | Sep 29, 1992 | SESE |
| K912820 | POLYESTER RESIN HAND MOLDED TRAY | E&D Dental Products, Inc. | Aug 21, 1991 | SESE |
| K905058 | PALAVIT L | Kulzer, Inc. | Jun 6, 1991 | SESE |
| K902350 | PALATRAY LC RESIN IMPRESSION TRAY MATERIAL | Kulzer, Inc. | Jul 26, 1990 | SESE |
| K901782 | CONVERTRAY CUSTOM IMPRESSION TRAY MATERIAL SYSTEM | Productivity Training Corp. | Jun 29, 1990 | SESE |
| K890712 | ADVANTAGE DENTAL CUST DENT IMPRESS/BASEPLATE TRAYS | Advantage Dental Products, Inc. | Apr 25, 1989 | SESE |
| K881838 | MODIFIED PERMAGUM ADHESIVE | Espe GmbH (Us) | Jul 27, 1988 | SESE |
| K875257 | IMPREGUM F ADHESIVE | Espe GmbH (Us) | Mar 9, 1988 | SESE |
| K875228 | PERMADYNE ADHESIVE | Espe GmbH (Us) | Mar 9, 1988 | SESE |
| K873739 | ACRYLIC IMPRESSION TRAY MATERIALS | E&D Dental Manufacturing Co. | Mar 7, 1988 | SESE |
| K872210 | IMPRESSION TRAY | Dentsply Intl. | Jun 22, 1987 | SESE |
| K863421 | SR-IVOLEN TRAY MATERIAL | Ivoclar USA, Inc. | Nov 3, 1986 | SESE |
| K854042 | RESIN TRAY IMPRESSION MATERIAL | Dentsply Intl. | Nov 7, 1985 | SESE |
| K853093 | PSP TEMP - TRAY | Psp Dental Co., Ltd. | Sep 6, 1985 | SESE |
| K852182 | EASY TRAY & EASY BASE CUSTOM IMPRESSION TRAY MATER | The S. S. White Co. | Jul 2, 1985 | SESE |
| K844471 | VISIBLE LIGHT-CURE COMPOSITE -POLISHABLE | Dentsply Intl. | Feb 8, 1985 | SESE |
| K850014 | HIT KIT (HYDRODYNAMIC IMPRESSION TECHNIQUE | Medi-Dent American, Inc. | Jan 23, 1985 | SESE |
Top Applicants
- Dentsply Intl. — 5 clearances
- Espe GmbH (Us) — 3 clearances
- Dentron, Inc. — 2 clearances
- Heraeus Kulzer, Inc. — 2 clearances
- Kulzer, Inc. — 2 clearances
