FDA.report

Earmould impression material

Definition
A rubber-like material used to replicate the shape of an individual's ear canal for the manufacture of custom-made hearing aids and earmoulds. The device may be supplied as a two-component silicone (base and catalyst) which produces the usable product. This is a single-use device.
GUDID devices
186
Last updated
2025-02-17 16:07:02

Related Product Codes

CodeDeviceSpecialtyClassDevices
ESDHearing Aid, Air-Conduction, PrescriptionEar, Nose, Throat1128
LDGKit, Earmold, ImpressionEar, Nose, Throat137
EWDProtector, Hearing (Insert)UnknownU16

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
G599103B0Aqua Plus Bulk BlueJkr Laboratories, Inc.103B2025-02-07
G599103R0Aqua Plus Bulk RedJkr Laboratories, Inc.103R2025-02-07
EDET025231addition ultra automix 2DETAX GmbH025232024-08-28
EDET033491aquaplus colormix yellow 8 x 50 ml DETAX GmbH033492024-08-28
EDET033501aquaplus colormix green8 x 50 ml DETAX GmbH033502024-08-28
EDET033541aquaplus colormix orange 8 x 50 ml DETAX GmbH033542024-08-28
EDET037391addition supra automix 2 8x50mlDETAX GmbH037392024-08-28
EDET041601addition Junior/DIC 4 x 50 mlDETAX GmbH041602024-08-28
EDET041661bioflex 40 blue 4x50mlDETAX GmbH041662024-08-28
EDET041671bioflex 40 rose 4x50mlDETAX GmbH041672024-08-28
EDET041681bioflex 40 red 4x50mlDETAX GmbH041682024-08-28
EDET041691bioflex 40 transparent 4x50mlDETAX GmbH041692024-08-28
EDET024231aquaplus colormix red/blue 8 x 50 ml DETAX GmbH024232024-05-28
G5991030Aqua Plus KitJkr Laboratories, Inc.1032024-02-12
G599103D0Aqua Plus Single Red 2x8 gJkr Laboratories, Inc.103D2024-02-12
G599103E0Aqua Plus Single Blue 2x8 gJkr Laboratories, Inc.103E2024-02-12
G599107A1Blue Ultra Cartridge 8x50 mlJkr Laboratories, Inc.107A2024-02-12
G599107C1Pink Ultra II Cartridge 8x50 mlJkr Laboratories, Inc.107C2024-02-12
G5991080Gold Velvet II Impression Single 2x8 gJkr Laboratories, Inc.1082024-02-12
G599970Gold Velvet II 10 unitJkr Laboratories, Inc.972024-02-12
G59997A0Gold Velvet II 40 unitJkr Laboratories, Inc.97A2024-02-12
G59997B0Gold Velvet II 80 unit Jkr Laboratories, Inc.97B2024-02-12
G599980XL-300 Impression 660 gJkr Laboratories, Inc.982024-02-12
G59998A0XL-300 Accelerator 25 gJkr Laboratories, Inc.98A2024-02-12
EPRCA0010200otosil IS-2pro3dure medical GmbH8 double cartridges of 2 x 25 ml2023-10-18
EPRCA0011000otosil PS-1pro3dure medical GmbH2 x 300g ; Orange - White2023-10-18
00850047788153Silicone SINGLES 24 PackWestone Laboratories, Inc.NA2023-08-25
00850047788160Silicone SINGLES 100 PackWestone Laboratories, Inc.NA2023-08-25
00850047788177Pink Silicast Westone Laboratories, Inc.NA2023-08-25
00850047788184Pink SilicastWestone Laboratories, Inc.NA2023-08-25
00850047788191EZ Mold Singles 24 Pk BlackWestone Laboratories, Inc.NA2023-08-25
00850047788207EZ Mold Singles 24 Pk BeigeWestone Laboratories, Inc.NA2023-08-25
00850047788214EZ Mold Singles 24 Pk PinkWestone Laboratories, Inc.NA2023-08-25
00850047788221EZ Mold Singles 24 Pk PurpleWestone Laboratories, Inc.NA2023-08-25
00850047788238EZ Mold Singles 24 Pk OrangeWestone Laboratories, Inc.NA2023-08-25
00850047788245EZ Mold Singles 24 Pk YellowWestone Laboratories, Inc.NA2023-08-25
00850047788252EZ Mold Singles 24 Pk GreenWestone Laboratories, Inc.NA2023-08-25
00850047788269EZ Mold Singles 24 Pk BlueWestone Laboratories, Inc.NA2023-08-25
00850047788276EZ Mold Singles 24 Pk BrownWestone Laboratories, Inc.NA2023-08-25
00850047788283EZ Mold Singles 24 Pk RedWestone Laboratories, Inc.NA2023-08-25
00850047788290EZ Mold Singles 24 Pk Forest Green Westone Laboratories, Inc.NA2023-08-25
00850047788306EZ Mold Singles 22 Pk AssortedWestone Laboratories, Inc.NA2023-08-25
00850047788313EZ Mold 8oz Tub Set BlackWestone Laboratories, Inc.NA2023-08-25
00850047788320EZ Mold 8oz Tub Set BeigeWestone Laboratories, Inc.NA2023-08-25
00850047788337EZ Mold 8oz Tub Set PinkWestone Laboratories, Inc.NA2023-08-25
00850047788344EZ Mold 8oz Tub Set PurpleWestone Laboratories, Inc.NA2023-08-25
00850047788351EZ Mold 8oz Tub Set OrangeWestone Laboratories, Inc.NA2023-08-25
00850047788368EZ Mold 8oz Tub Set YellowWestone Laboratories, Inc.NA2023-08-25
00850047788375EZ Mold 8oz Tub Set GreenWestone Laboratories, Inc.NA2023-08-25
00850047788382EZ Mold 8oz Tub Set BlueWestone Laboratories, Inc.NA2023-08-25
00850047788399EZ Mold 8oz Tub Set BrownWestone Laboratories, Inc.NA2023-08-25
00850047788405EZ Mold 8oz Tub Set RedWestone Laboratories, Inc.NA2023-08-25
00850047788412EZ Mold 8oz Tub Set Forest GreenWestone Laboratories, Inc.NA2023-08-25
00850047788429Blue Silicast Westone Laboratories, Inc.NA2023-08-25
00850047788436Blue Silicast HardenerWestone Laboratories, Inc.NA2023-08-25
00850047788467Impression Taking Starter KitWestone Laboratories, Inc.NA2023-08-25
00850047788474Impression Taking Refill KitWestone Laboratories, Inc.NA2023-08-25
00850047788481Impression Taking Starter Kit InternationalWestone Laboratories, Inc.NA2023-08-25
00850047788498Impression Taking Refill Kit International Westone Laboratories, Inc.NA2023-08-25
00850047788504Impression Taking Traveler KitWestone Laboratories, Inc.NA2023-08-25
00850047788511Impression Taking Traveler Kit InternationalWestone Laboratories, Inc.NA2023-08-25
EDET021361classic futur white 660gDETAX GmbH021362023-07-03
EDET032021addition spectra budget packing automix 1DETAX GmbH032022023-07-03
EDET034421addition protect 8 x 50mlDETAX GmbH034422023-07-03
EDET022711detax addition blue 2 x 5000 mlDETAX GmbH022712023-06-30
EDET035001pink putty 2 x 8 gDETAX GmbH035002023-06-30
EDET023341aquaplus blue 50 mlDETAX GmbH023342023-06-29
EDET028491aquaplus red 50 mlDETAX GmbH028492023-06-29
EDET034391addition mini Junior StandardpackDETAX GmbH034392023-06-29
EDET035221pink putty single setDETAX GmbH035222023-06-29
EDET023971classic futur red 660gDETAX GmbH023972023-06-28
EPRCA1040153PRO3DURE L-1pro3dure medical GmbH250 g - Black Translucent2022-12-06
EPRCA1040209PRO3DURE L-1pro3dure medical GmbH50 g - lightblue transparent 2022-12-06
EPRCA1040402PRO3DURE L-1pro3dure medical GmbH250 g - Red Transparent 2022-12-06
EPRCA1040403PRO3DURE L-1pro3dure medical GmbH250 g - Reddish Transparent 2022-12-06
EPRCA1040404PRO3DURE L-1pro3dure medical GmbH250 g - Blue Transparent 2022-12-06
EPRCA1040412PRO3DURE L-1pro3dure medical GmbH250 g - Uncolored2022-12-06
00850047788009Siliclone X-Act with 4 TipsWestone Laboratories, Inc.NA2022-11-29
00850047788016Siliclone X-Act 8pk No tipsWestone Laboratories, Inc.NA2022-11-29
00850047788023Siliclone X-Act 8pk 32 tipsWestone Laboratories, Inc.NA2022-11-29