Product code EBH
- Device name
- Material, Impression Tray, Resin
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.3670
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K933745 | PERMAGEN UNIVERSAL BONDING RESIN | Bio-Systems Research | 1994-01-26 |
| K930487 | PALATRAY LC MINT | Heraeus Kulzer, Inc. | 1993-06-18 |
| K923979 | LC TRAY MATERIAL | Dentsply Intl. | 1992-11-17 |
| K923549 | PALADISC LC | Heraeus Kulzer, Inc. | 1992-09-29 |
| K912820 | POLYESTER RESIN HAND MOLDED TRAY | E&D Dental Products, Inc. | 1991-08-21 |
| K905058 | PALAVIT L | Kulzer, Inc. | 1991-06-06 |
| K902350 | PALATRAY LC RESIN IMPRESSION TRAY MATERIAL | Kulzer, Inc. | 1990-07-26 |
| K901782 | CONVERTRAY CUSTOM IMPRESSION TRAY MATERIAL SYSTEM | Productivity Training Corp. | 1990-06-29 |
| K890712 | ADVANTAGE DENTAL CUST DENT IMPRESS/BASEPLATE TRAYS | Advantage Dental Products, Inc. | 1989-04-25 |
| K881838 | MODIFIED PERMAGUM ADHESIVE | Espe GmbH (Us) | 1988-07-27 |
| K875257 | IMPREGUM F ADHESIVE | Espe GmbH (Us) | 1988-03-09 |
| K875228 | PERMADYNE ADHESIVE | Espe GmbH (Us) | 1988-03-09 |
| K873739 | ACRYLIC IMPRESSION TRAY MATERIALS | E&D Dental Manufacturing Co. | 1988-03-07 |
| K872210 | IMPRESSION TRAY | Dentsply Intl. | 1987-06-22 |
| K863421 | SR-IVOLEN TRAY MATERIAL | Ivoclar USA, Inc. | 1986-11-03 |
| K854042 | RESIN TRAY IMPRESSION MATERIAL | Dentsply Intl. | 1985-11-07 |
| K853093 | PSP TEMP - TRAY | Psp Dental Co., Ltd. | 1985-09-06 |
| K852182 | EASY TRAY & EASY BASE CUSTOM IMPRESSION TRAY MATER | The S. S. White Co. | 1985-07-02 |
| K844471 | VISIBLE LIGHT-CURE COMPOSITE -POLISHABLE | Dentsply Intl. | 1985-02-08 |
| K850014 | HIT KIT (HYDRODYNAMIC IMPRESSION TECHNIQUE | Medi-Dent American, Inc. | 1985-01-23 |
| K831293 | SOLARCRYL CUSTOM TRAY MATERIAL | Solar Dental Co., Inc. | 1983-07-26 |
| K820998 | DENTRON-DIRECT-TRAY | Dentron, Inc. | 1982-06-10 |
| K820997 | DENTRON-EXACT - TRAY | Dentron, Inc. | 1982-06-10 |
| K813550 | HYBRID DENTAL PRODUCT | Dentsply Intl. | 1982-02-24 |
| K810686 | SR-IVOLEN | J. Aderer, Inc. | 1981-04-14 |
| K802751 | P-10 POSTERIOR FILLING MATERIAL | 3M Company | 1980-11-12 |
| K801780 | OXY CUSTOM TRAY RESIN | Oxy Dental Products, Inc. | 1980-08-07 |
| K790897 | QUAD IV CUSTOM IMPRESSION TRAY | Sted, Inc. | 1979-06-15 |
| K782153 | IMPRESSION TRAY, MDDS CUSTOM | Chayet and Sonnenrich, P.C. | 1979-02-26 |
| K760754 | CUTTER TRAY-ACRYLIC FOR IMP TRAYS | Cutter Laboratories, Inc. | 1976-10-15 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08800017902074 | Disposable Impression Bite Tray | DXM CO., LTD | 2024-06-11 |
| 08800017902043 | Disposable Impression Bite Tray | DXM CO., LTD | 2024-06-11 |
| H66870001901 | Proform | Keystone Industries | 2022-11-30 |
| H668210061 | American Dental | Keystone Industries | 2022-11-30 |
| H668210051 | American Dental | Keystone Industries | 2022-11-30 |
| H668210041 | American Dental | Keystone Industries | 2022-11-30 |
| 07615208421071 | SR Ivolen | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2022-11-14 |
| 07615208303056 | SR Ivolen | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2022-11-14 |
| 08800053007344 | ZMD-1000B TRAY | DENTIS CO. ,LTD | 2021-05-28 |
| 08719425508825 | Ceramill | Vertex-Dental B.V. | 2019-02-15 |
| 08719425508795 | Ceramill | Vertex-Dental B.V. | 2019-02-12 |
| 08719425508085 | Vertex-Dental BV | Vertex-Dental B.V. | 2018-03-12 |
| 08719425503400 | Vertex-Dental BV | Vertex-Dental B.V. | 2018-03-12 |
| 08719425507903 | Vertex-Dental BV | Vertex-Dental B.V. | 2018-03-12 |
| 08719425507910 | Vertex-Dental BV | Vertex-Dental B.V. | 2018-03-12 |
| 08719425507927 | Vertex-Dental BV | Vertex-Dental B.V. | 2018-03-12 |
| 08719425507934 | Vertex-Dental BV | Vertex-Dental B.V. | 2018-03-12 |
| 08719425507941 | Vertex-Dental BV | Vertex-Dental B.V. | 2018-03-12 |
| 08719425508061 | Vertex-Dental BV | Vertex-Dental B.V. | 2018-03-12 |
| 08719425508054 | Vertex-Dental BV | Vertex-Dental B.V. | 2018-03-12 |
| 08719425508047 | Vertex-Dental BV | Vertex-Dental B.V. | 2018-03-12 |
| 08719425508030 | Vertex-Dental BV | Vertex-Dental B.V. | 2018-03-12 |
| 08719425508023 | Vertex-Dental BV | Vertex-Dental B.V. | 2018-03-12 |
| 08719425508016 | Vertex-Dental BV | Vertex-Dental B.V. | 2018-03-12 |
| 08719425507996 | Vertex-Dental BV | Vertex-Dental B.V. | 2018-03-12 |
| 08719425507972 | Vertex-Dental BV | Vertex-Dental B.V. | 2018-03-12 |
| 08719425507965 | Vertex-Dental BV | Vertex-Dental B.V. | 2018-03-12 |
| 08719425507958 | Vertex-Dental BV | Vertex-Dental B.V. | 2018-03-12 |
| H65857004550 | Henry Schein | HENRY SCHEIN, INC. | 2017-01-06 |
| H65857004560 | Henry Schein | HENRY SCHEIN, INC. | 2017-01-06 |