FDA.reportPublic FDA data

COE®

Primary DI
10386040001892
Brand
COE®
Company
Gc America Inc.
Model
250112
Catalog number
250112
Device description
PERF SPACER MASTER 1EA 1D-22D
Published
2022-08-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBHMATERIAL, IMPRESSION TRAY, RESIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBHMaterial, Impression Tray, ResinDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10386040001892PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038604000189210386040001892

GMDN Terms#

Term, Definition table
TermDefinition
Dental impression tray, single-useA horseshoe-shaped receptacle made of metal or plastic designed to carry dental impression material to the mouth, to confine the material in opposition to the surfaces to be recorded (e.g., teeth and gums), and to control the impression material while it sets to form an impression. The device is used mainly to facilitate the manufacturing of custom dental prostheses (e.g., dentures). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(708)597-0900customerservice@gcamerica.com

Regulatory Flags#

DUNS number
005473608
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14550565002269Cytrans Granules10041295100412952026-03-03
14550565002276Cytrans Granules10041296100412962026-03-03
D047014615Cytrans Granules10041295100412952026-03-03
D047014616Cytrans Granules10041296100412962026-03-03
D6581200012COE ALGINATE™1200011200012016-08-01
D6581200051COE ALGINATE™1200051200052016-08-01
D6581200251COE ALGINATE™1200251200252016-08-01
D6581201012COE ALGINATE™1201011201012016-08-01
D6581210012COE ALGINATE™1210011210012016-08-01
D6581211012COE ALGINATE™1211011211012016-08-01
D6581240012COE HYDROPHILIC GEL™1240011240012016-08-01
D6581241012COE HYDROPHILIC GEL™1241011241012016-08-01
D6581241251COE HYDROPHILIC GEL™1241251241252016-08-01
D6581310022COE-FLEX®1310021310022016-08-01
D6581310032COE-FLEX®1310031310032016-08-01
D6581310042COE-FLEX®1310041310042016-08-01
D6581310052COE-FLEX®1310051310052016-08-01
D6581311022COE-FLEX®1311021311022016-08-01
D6581311032COE-FLEX®1311031311032016-08-01
D6581311042COE-FLEX®1311041311042016-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08906139320670Taglus Model ResinLAXMI DENTAL LIMITEDEBH2026-01-09
08906139320694Taglus Model Resin SLAXMI DENTAL LIMITEDEBH2026-01-09
08906139323473Taglus Model Resin OdourlessLAXMI DENTAL LIMITEDEBH2026-01-09
06975338701292SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBH2025-12-09
06975338701308SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBH2025-12-09
00850061175151H-0600 ResinFORMLABS OHIO INC.EBH2025-12-01
EDET047221RS VIVO IBT 1000gDETAX GmbHEBH2025-11-20
E235S3DMR0DentaprintSHOFU DENTAL CORPORATIONEBH2025-08-26
E235S3DOR0DentaprintSHOFU DENTAL CORPORATIONEBH2025-08-26
07701126901075Portux 3D Printing Resin Basic Gray x 500gPRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S AEBH2025-08-11
07701126901204Portux 3D Printing Resin Dental ModelsPRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S AEBH2025-08-11
07701126901235Portux 3D Printing Resin Model 2.0PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S AEBH2025-08-11
04260635981587RS VIVO TrayDeltaMed GmbHEBH2025-07-29
EDEL162162003Delta Tray RoseDeltaMed GmbHEBH2025-07-29
D7091084045M-PRINT TryInMerz Dental GmbHEBH2025-07-08
D7091084046M-PRINT TryInMerz Dental GmbHEBH2025-07-08
D7091084047M-PRINT TryInMerz Dental GmbHEBH2025-07-08
D7091084048M-PRINT TryInMerz Dental GmbHEBH2025-07-08
16978499313042RAYFORM TechnologyZiyang Rayform Technology Co., Ltd.EBH2025-05-09
EPRC768507UCAN Print Traypro3dure medical GmbHEBH2025-03-31
E239D4210ZS1DrufoplastDreve Dentamid GmbHEBH2025-03-21
06975471800036PionextShenzhen Piocreat 3D Technology Co., LtdEBH2024-12-26
06975471800043PionextShenzhen Piocreat 3D Technology Co., LtdEBH2024-12-26
06975471800050PionextShenzhen Piocreat 3D Technology Co., LtdEBH2024-12-26
06975471800067PionextShenzhen Piocreat 3D Technology Co., LtdEBH2024-12-26
06975471800074PionextShenzhen Piocreat 3D Technology Co., LtdEBH2024-12-26
06975471800081PionextShenzhen Piocreat 3D Technology Co., LtdEBH2024-12-26
06975471800098PionextShenzhen Piocreat 3D Technology Co., LtdEBH2024-12-26
06975471800104PionextShenzhen Piocreat 3D Technology Co., LtdEBH2024-12-26
06975471800111PionextShenzhen Piocreat 3D Technology Co., LtdEBH2024-12-26