FDA.reportPublic FDA data

Hardener paste

Primary DI
E239521121
Brand
Hardener paste
Company
Dreve Otoplastik GmbH
Model
52112
Catalog number
52112
Device description
No.
Published
2022-08-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
LDGKit, earmold, impression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDGKit, Earmold, ImpressionEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E239521121PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Earmould impression kitA collection of non-sterile supplies, instruments, and materials intended to be used to make an accurate impression of the folds and convolutions of cartilage that form the outer ear and its canal (i.e., an earmould). It typically includes a foam or cotton block, a mixing bowl, a spatula, impression liquid and/or powder; it also includes either a syringe or tube to deliver the impression material, or less frequently an impression tray for direct moulding. The mould of the ear is used to manufacture custom-made hearing devices such as hearing aids and earplugs. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature18 Degrees Celsius28 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49230388070otoplastik@dreve.de

Regulatory Flags#

DUNS number
315808340
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
E239904001FotoTec® DLP.C90400904002026-01-30
E239905001FotoTec® DLP.C90500905002026-01-30
E239361001FotoTec® DLP.B36100361002022-09-15
E239906001FotoTec® DLP.C90600906002026-01-15
E239903001FotoTec® DLP.C90300903002025-07-09
E239908001FotoTec® DLP.C90800908002025-07-09
E2399095011FotoTec® DLP.C9095019095012025-07-09
E239901001FotoTec® DLP.C90100901002025-04-02
E2392936M1Otoform® A flex2936M2936M2025-01-20
E2392956M1Otoform® A softX2956M2956M2025-01-20
E2393206M1Otoform® A soft3206M3206M2025-01-20
E23904171101Pre-bent tubing041711004171102025-01-13
E23904171501Pre-bent tubing041715004171502025-01-13
E239042501Pre-bent tubing04250042502025-01-13
E23911311Silicone tubing113111312025-01-13
E23920211Silicone tubing202120212025-01-13
E2392291001Arc tubing connection2291002291002025-01-13
E239229101Arc tubing connection22910229102025-01-13
E239234101Pre-bent tubing23410234102025-01-13
E2395041Otoform® Kc5045042025-01-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00365044000080ComforTen® 60-hole covered trayJubilant Hollisterstier LLCLDG2026-03-02
D239206411egger A/ITE varioInnovation MediTech GmbHLDG2025-08-29
E2392064111egger A/ITE varioInnovation MediTech GmbHLDG2025-08-29
E2392936M1Otoform® A flexDreve Otoplastik GmbHLDG2025-01-20
E2392956M1Otoform® A softXDreve Otoplastik GmbHLDG2025-01-20
E2393206M1Otoform® A softDreve Otoplastik GmbHLDG2025-01-20
E2395041Otoform® KcDreve Otoplastik GmbHLDG2025-01-13
E2398802AU1Otoform® A softX Dreve Otoplastik GmbHLDG2024-03-13
E2398802ST1Otoform® A softX Dreve Otoplastik GmbHLDG2024-03-13
E2398802M1Otoform® A softXDreve Otoplastik GmbHLDG2023-12-18
E23988021Otoform® A softX Dreve Otoplastik GmbHLDG2023-10-31
EPRCA0010200otosil IS-2pro3dure medical GmbHLDG2023-10-18
EPRCA0011000otosil PS-1pro3dure medical GmbHLDG2023-10-18
00850047788153Silicone SINGLES 24 PackWestone Laboratories, Inc.LDG2023-08-25
00850047788160Silicone SINGLES 100 PackWestone Laboratories, Inc.LDG2023-08-25
00850047788177Pink Silicast Westone Laboratories, Inc.LDG2023-08-25
00850047788184Pink SilicastWestone Laboratories, Inc.LDG2023-08-25
00850047788191EZ Mold Singles 24 Pk BlackWestone Laboratories, Inc.LDG2023-08-25
00850047788207EZ Mold Singles 24 Pk BeigeWestone Laboratories, Inc.LDG2023-08-25
00850047788214EZ Mold Singles 24 Pk PinkWestone Laboratories, Inc.LDG2023-08-25
00850047788221EZ Mold Singles 24 Pk PurpleWestone Laboratories, Inc.LDG2023-08-25
00850047788238EZ Mold Singles 24 Pk OrangeWestone Laboratories, Inc.LDG2023-08-25
00850047788245EZ Mold Singles 24 Pk YellowWestone Laboratories, Inc.LDG2023-08-25
00850047788252EZ Mold Singles 24 Pk GreenWestone Laboratories, Inc.LDG2023-08-25
00850047788269EZ Mold Singles 24 Pk BlueWestone Laboratories, Inc.LDG2023-08-25
00850047788276EZ Mold Singles 24 Pk BrownWestone Laboratories, Inc.LDG2023-08-25
00850047788283EZ Mold Singles 24 Pk RedWestone Laboratories, Inc.LDG2023-08-25
00850047788290EZ Mold Singles 24 Pk Forest Green Westone Laboratories, Inc.LDG2023-08-25
00850047788306EZ Mold Singles 22 Pk AssortedWestone Laboratories, Inc.LDG2023-08-25
00850047788313EZ Mold 8oz Tub Set BlackWestone Laboratories, Inc.LDG2023-08-25