Atlas FDA

EBH

30 FDA 510(k) clearances · Product code

62 daysmedian time to decision
174 days90th percentile
30clearances measured

FDA profile

Official device name
Material, Impression Tray, Resin
Device class
Class I (low risk)
Regulation
21 CFR 872.3670
Medical specialty
Dental
Flags
GMP exempt
Adverse events (MAUDE)
1998: 1 · 1999: 1 · 2005: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
PERMAGEN UNIVERSAL BONDING RESIN (K933745)Bio-Systems Research1994-01-26
PALATRAY LC MINT (K930487)Heraeus Kulzer, Inc.1993-06-18
LC TRAY MATERIAL (K923979)Dentsply Intl.1992-11-17
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
IMPRESSION TRAY (K872210)Dentsply Intl.1987-06-22
SR-IVOLEN TRAY MATERIAL (K863421)Ivoclar USA, Inc.1986-11-03
RESIN TRAY IMPRESSION MATERIAL (K854042)Dentsply Intl.1985-11-07
PSP TEMP - TRAY (K853093)Psp Dental Co., Ltd.1985-09-06
EASY TRAY & EASY BASE CUSTOM IMPRESSION TRAY MATER (K852182)The S. S. White Co.1985-07-02
VISIBLE LIGHT-CURE COMPOSITE -POLISHABLE (K844471)Dentsply Intl.1985-02-08
HIT KIT (HYDRODYNAMIC IMPRESSION TECHNIQUE (K850014)Medi-Dent American, Inc.1985-01-23
SOLARCRYL CUSTOM TRAY MATERIAL (K831293)Solar Dental Co., Inc.1983-07-26
DENTRON-DIRECT-TRAY (K820998)Dentron, Inc.1982-06-10
DENTRON-EXACT - TRAY (K820997)Dentron, Inc.1982-06-10
HYBRID DENTAL PRODUCT (K813550)Dentsply Intl.1982-02-24
SR-IVOLEN (K810686)J. Aderer, Inc.1981-04-14
P-10 POSTERIOR FILLING MATERIAL (K802751)3M Company1980-11-12
OXY CUSTOM TRAY RESIN (K801780)Oxy Dental Products, Inc.1980-08-07
QUAD IV CUSTOM IMPRESSION TRAY (K790897)Sted, Inc.1979-06-15
IMPRESSION TRAY, MDDS CUSTOM (K782153)Chayet and Sonnenrich, P.C.1979-02-26
CUTTER TRAY-ACRYLIC FOR IMP TRAYS (K760754)Cutter Laboratories, Inc.1976-10-15

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Every clearance here is in the API, with alerts when new ones post.