FDA.reportPublic FDA data

NA

Primary DI
04963931210794
Brand
NA
Company
YDM CORPORATION
Model
21079
Catalog number
21079
Device description
The intended medical indication is grasping and removing a crown that has been tried into the oral cavity.
Published
2025-12-05
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
EISRemover, Crown

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EISRemover, CrownDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04963931210794PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04963931210794049639312107944963931210794

GMDN Terms#

Term, Definition table
TermDefinition
Dental prosthesis removal instrumentA non-electric, hand-held dental instrument intended to be used to remove a permanent or temporary cemented dental prosthesis restoration (e.g., crown, denture, bridge) from a tooth or implant abutment; it is not a thermal detacher. It consists of a metallic instrument with a handle and a pointed, angled distal end used to secure the instrument at the margin of the prosthesis to be removed; it may be designed as a manual, pneumatic or spring-loaded instrument whereby light force is applied to detach the restoration; some types are referred to as crown spreaders. 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
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
04963931276028NA27602276022023-05-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB4270TBS BASICSACME ENTERPRISE.EIS2026-05-20
00348783010114Premier Crown RemoversPREMIER DENTAL PRODUCTS COMPANYEIS2026-04-02
00348783010121Premier Crown RemoversPREMIER DENTAL PRODUCTS COMPANYEIS2026-04-02
00348783010138Premier Crown RemoversPREMIER DENTAL PRODUCTS COMPANYEIS2026-04-02
00348783010145Premier Crown RemoversPREMIER DENTAL PRODUCTS COMPANYEIS2026-04-02
00348783010152Premier Crown RemoversPREMIER DENTAL PRODUCTS COMPANYEIS2026-04-02
00348783010169Premier Crown RemoversPREMIER DENTAL PRODUCTS COMPANYEIS2026-04-02
00348783010176Premier Crown RemoversPREMIER DENTAL PRODUCTS COMPANYEIS2026-04-02
G14934001F08TBS DentalACME ENTERPRISE.EIS2026-03-02
04963931210800NAYDM CORPORATIONEIS2025-12-05
00841336106086Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIS2025-11-11
00841336108646Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIS2025-11-11
00841336108660Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIS2025-11-11
08800075627346OSUNG MNDOSUNG MND Co., Ltd.EIS2025-11-03
08800075627353OSUNG MNDOSUNG MND Co., Ltd.EIS2025-11-03
00841336100916Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIS2024-12-11
00841336125551Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIS2024-12-11
00841336125568Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIS2024-12-11
00841336125575Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIS2024-12-11
00841336125582Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIS2024-12-11
00841336125599Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIS2024-12-11
06974456210815CICADAFoshan Cicada Dental Instrument Co., Ltd.EIS2024-08-10
00813677025098PDT, Inc.PDT, INC.EIS2024-07-03
00813677023292PDT, Inc.PDT, INC.EIS2024-07-02
00813677024565PDT, Inc.PDT, INC.EIS2024-07-02
00813677023285PDT, Inc.PDT, INC.EIS2024-07-01
00813677023544PDT, Inc.PDT, INC.EIS2024-07-01
00813677023551PDT, Inc.PDT, INC.EIS2024-07-01
D105SKU1311760SurgiMac Surgimac LLCEIS2024-05-10
00842517107366Karl SchumacherKarl Schumacher Dental, LLCEIS2024-03-18