FDA.reportPublic FDA data

NA

Primary DI
04963931071609
Brand
NA
Company
YDM CORPORATION
Model
07160
Catalog number
07160
Device description
A dental instrument used to carve wax patterns, which can be heated for softening the wax while fashioning the pattern.
Published
2022-09-30
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
EIKCarver, Wax, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIKCarver, Wax, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04963931071609PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04963931071609049639310716094963931071609

GMDN Terms#

Term, Definition table
TermDefinition
Dental wax carverA hand-held manual dental instrument used to carve wax patterns with a blunt blade of varying size and shape, which can be heated for softening the wax while fashioning the pattern. This is a reusable device.

Sterilization Methods#

Method table
Method

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

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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Primary DI, Brand, Company table
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G149TBSB8100TBS BASICSACME ENTERPRISE.EIK2026-05-18
G149TBSB8110TBS BASICSACME ENTERPRISE.EIK2026-05-18
G149TBSB8120TBS BASICSACME ENTERPRISE.EIK2026-05-18
G149TBSB8140TBS BASICSACME ENTERPRISE.EIK2026-05-18
G149TBSB8150TBS BASICSACME ENTERPRISE.EIK2026-05-18
G149TBSB8050TBS BASICSACME ENTERPRISE.EIK2026-05-17
G149TBSB8060TBS BASICSACME ENTERPRISE.EIK2026-05-17
G149TBSB8070TBS BASICSACME ENTERPRISE.EIK2026-05-17
G149TBSB8160TBS BASICSACME ENTERPRISE.EIK2026-05-17
G149TBSB8170TBS BASICSACME ENTERPRISE.EIK2026-05-17
00348783010077Premier Lab InstrumentsPREMIER DENTAL PRODUCTS COMPANYEIK2026-04-28
00348783010084Premier Lab InstrumentsPREMIER DENTAL PRODUCTS COMPANYEIK2026-04-28
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00348783010107Premier Lab InstrumentsPREMIER DENTAL PRODUCTS COMPANYEIK2026-04-28
00348783010060Premier Lab InstrumentsPREMIER DENTAL PRODUCTS COMPANYEIK2026-04-27
00348783012309Premier CarversPREMIER DENTAL PRODUCTS COMPANYEIK2026-04-01
08404535024906Brasseler USAPeter Brasseler Holdings, LLCEIK2026-03-23
08404535024937Brasseler USAPeter Brasseler Holdings, LLCEIK2026-03-23
08404535024968Brasseler USAPeter Brasseler Holdings, LLCEIK2026-03-23
00840018666016Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIK2026-02-09
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00840018661172Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIK2026-01-28
00840018661301Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIK2026-01-28
08800075627551OSUNG MNDOSUNG MND Co., Ltd.EIK2025-11-03