FDA.reportPublic FDA data

HANDY IIM

Primary DI
E23550750
Brand
HANDY IIM
Company
SHOFU DENTAL CORPORATION
Model
5075
Catalog number
5075
Device description
GUIDE PIN
Published
2021-02-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EJPARTICULATORS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJPArticulatorsDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E23550750PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental articulatorA hinged, mechanical, dental device designed to simulate the movement of a patient's upper and lower jaws and onto which maxillary and mandibular casts or models are attached according to a pre-recorded intermaxillary relationship. It is designed to simulate all or part of the mandibular movements and is used for, e.g., examination, diagnosis, or to construct dental appliances. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)827-5262customer-service@shofu.com

Regulatory Flags#

DUNS number
054618202
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04548162300836ResiCem EXC0100C01002026-07-04
04548162300843ResiCem EXC0101C01012026-07-04
04548162300850ResiCem EXC0102C01022026-07-04
04548162300867ResiCem EXC0103C01032026-07-04
04548162344113ResiCem EXC0104C01042026-07-04
04548162350558GlossMaster ZRN0012N00122026-07-04
04548162350565GlossMaster ZRN0013N00132026-07-04
04548162350572GlossMaster ZRN0014N00142026-07-04
04548162350589GlossMaster ZRN0015N00152026-07-04
04548162350596GlossMaster ZRN0016N00162026-07-04
04548162350602GlossMaster ZRN0017N00172026-07-04
04548162350619GlossMaster ZRN0018N00182026-07-04
04548162350626GlossMaster ZRN0019N00192026-07-04
04548162350633GlossMaster ZRN0020N00202026-07-04
04548162350640GlossMaster ZRN0021N00212026-07-04
04548162350657GlossMaster ZRN0022N00222026-07-04
04548162350664GlossMaster ZRN0023N00232026-07-04
E235Y00030SHOFU RESIN GLAZEY0003Y00032026-06-08
E235Y00040SHOFU RESIN GLAZEY0004Y00042021-02-03
E235DPC0DentaprintDPCDPC2026-04-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D040342160MA2340 W/STRAPSWHIP-MIX CORPORATIONEJP2025-09-11
00348783005813W.O.W.™PREMIER DENTAL PRODUCTS COMPANYEJP2024-06-06
00348783005820W.O.W.™PREMIER DENTAL PRODUCTS COMPANYEJP2024-06-06
00348783005837W.O.W.™PREMIER DENTAL PRODUCTS COMPANYEJP2024-06-06
00348783005844W.O.W.™PREMIER DENTAL PRODUCTS COMPANYEJP2024-06-06
00348783005851W.O.W.™ 2PREMIER DENTAL PRODUCTS COMPANYEJP2024-06-06
D040200113770Denar Mark 310 ArticulatorWHIP-MIX CORPORATIONEJP2024-02-27
D040200113780Denar Mark 320 ArticulatorWHIP-MIX CORPORATIONEJP2024-02-27
D040200114080Denar Mark 330 ArticulatorWHIP-MIX CORPORATIONEJP2024-02-27
08800075601490OSUNG MNDOSUNG MND Co., Ltd.EJP2024-02-22
08964003163570Doctor NiceB. Ali ImpexEJP2024-01-29
08964003163587ECCOB. Ali ImpexEJP2024-01-29
E1997592331ArticulatorCandulor AGEJP2023-10-18
00816063020677iTero Articulator KitAlign Technology, Inc.EJP2021-06-04
E23550700HANDY IIMSHOFU DENTAL CORPORATIONEJP2021-02-03
E23550710HANDY IIMSHOFU DENTAL CORPORATIONEJP2021-02-03
E23550730HANDY IIMSHOFU DENTAL CORPORATIONEJP2021-02-03
E23550740HANDY IIMSHOFU DENTAL CORPORATIONEJP2021-02-03
E23550760HANDY IIMSHOFU DENTAL CORPORATIONEJP2021-02-03
D0400033020001Hanau 96 H2 ArticulatorWHIP-MIX CORPORATIONEJP2020-09-22
D0400098560001Hanau-Mate Non-Adjustable ArticulatorWHIP-MIX CORPORATIONEJP2020-09-22
D0400108850001Hanau Wide-Vue ArticulatorWHIP-MIX CORPORATIONEJP2020-09-22
D0400141020001Hanau modular ArticulatorWHIP-MIX CORPORATIONEJP2020-09-22
D0400141160001Hanau modular ArticulatorWHIP-MIX CORPORATIONEJP2020-09-22
D0400143000001Hanau modular ArticulatorWHIP-MIX CORPORATIONEJP2020-09-22
D0400143090001Hanau modular ArticulatorWHIP-MIX CORPORATIONEJP2020-09-22
D0400145030001Hanau modular ArticulatorWHIP-MIX CORPORATIONEJP2020-09-22
D0400224614640 Q ArticulatorWHIP-MIX CORPORATIONEJP2020-09-22
D0400226712240 ArticulatorWHIP-MIX CORPORATIONEJP2020-09-22
D0400227814641 ArticulatorWHIP-MIX CORPORATIONEJP2020-09-22