FDA.reportPublic FDA data

NA

Primary DI
04963931194674
Brand
NA
Company
YDM CORPORATION
Model
19467
Catalog number
19467
Device description
A horseshoe-shaped receptacle made of metal 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.
Published
2022-10-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
04963931194674PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04963931194674049639311946744963931194674

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
+819019940653jumpei@ydm.co.jp

Regulatory Flags#

DUNS number
716059766
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04963931210794NA21079210792025-12-05
04963931210800NA21080210802025-12-05
04963931274291NA27429274292025-07-11
04963931274659NA27465274652025-04-03
04963931274666NA27466274662025-04-03
04963931227211NA22721227212024-04-01
04963931227228NA22722227222024-04-01
04963931227266NA22726227262024-04-01
04963931276103NA27610276102024-04-01
04963931102013NA10201102012024-02-08
04963931102020NA10202102022024-02-08
04963931102037NA10203102032024-02-08
04963931102051NA10205102052024-02-08
04963931271313NA27131271312024-02-08
04963931271320NA27132271322024-02-08
04963931271337NA27133271332024-02-08
04963931271344NA27134271342024-02-08
04963931271351NA271345271352024-02-08
04963931271368NA271346271362024-02-08
04963931276011NA27601276012023-05-16

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D1254174Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
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