FDA.reportPublic FDA data

KOHDENT

Primary DI
04251436920295
Brand
KOHDENT
Company
Kohler Medizintechnik GmbH
Model
6640
Catalog number
6640
Device description
WINTRAY - Impression Tray -U3A-S 1 key 6639, 4 screws 6638
Published
2021-08-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EHYTRAY, IMPRESSION, PREFORMED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHYTray, Impression, PreformedDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251436920295PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251436920295042514369202954251436920295

GMDN Terms#

Term, Definition table
TermDefinition
Dental impression tray, reusableA 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 reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+497771649990info@kohler-medizintechnik.de

Regulatory Flags#

DUNS number
344386737
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04251436919084Kohler6414-CC2026-04-23
04251436943850Kohler83142026-04-23
04251436909030KOHLER451645162026-03-12
04251436934155KOHLER451645162026-03-12
04251436931086KOHLER955795572026-03-12
04251436943805KOHLER842884282026-03-12
04251436943812KOHLER8461-CC8461-CC2026-03-12
04251436943836KOHLER8401-N8401-N2026-03-12
04251436943843KOHLER330833082026-03-12
04251436907746KOHDENT430643062021-08-30
04251436943492KOHDENT670067002023-11-28
04251436915819KOHDENT573957392021-09-22
04251436915826KOHDENT574057402021-09-22
04251436915833KOHDENT574157412021-09-22
04251436918094KOHDENT616361632021-09-22
04251436918100KOHDENT616661662021-09-22
04251436918179KOHDENT620962092021-09-22
04251436918186KOHDENT621062102021-09-22
04251436918834KOHDENT635863582021-09-22
04251436921209KOHDENT679267922021-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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D1254114Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
D1254124Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
D1254134Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
D1254144Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
D1254154Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
D1254164Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
D1254174Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
D1254184Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
D1254194Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
D1254204Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
D1254304Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
08961104622654Impression Tray SetMELPEX BEAUTY INSTRUMENTSEHY2026-05-21
08961104622661Impression Tray SetMELPEX BEAUTY INSTRUMENTSEHY2026-05-21
08906139322087Taglus Impression TrayLAXMI DENTAL LIMITEDEHY2026-01-09
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00190707110895DuraLock®Ortho Organizers, Inc.EHY2025-09-25
07615208301304Centric TrayIVOCLAR VIVADENT AKTIENGESELLSCHAFTEHY2025-03-20