FDA.reportPublic FDA data

SUPER-SNAP

Primary DI
E23504380
Brand
SUPER-SNAP
Company
SHOFU DENTAL CORPORATION
Model
0438
Catalog number
0438
Device description
FG SUPER SNAP MANDREL
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
EJLBUR, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJLBur, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E23504380PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental mandrelA slender, round, metal shaft designed to be used chairside to hold (locked into place) a rotating dental device, e.g., a grinding wheel, abrasive disk, circular saw, or a disk, stone or cup used for grinding or polishing. The mandrel will be placed into a dental handpiece that will rotate at high speed. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E235DD16A1ML0DENTADISCDD16A1MLDD16A1ML2026-07-09
E235DD16A1MN0DENTADISCDD16A1MNDD16A1MN2026-07-09
E235DD16A2ML0DENTADISCDD16A2MLDD16A2ML2026-07-09
E235DD16A2MN0DENTADISCDD16A2MNDD16A2MN2026-07-09
E235DD16A35MN0DENTADISCDD16A35MNDD16A35MN2026-07-09
E235DD16A3MN0DENTADISCDD16A3MNDD16A3MN2026-07-09
E235DD16B1ML0DENTADISCDD16B1MLDD16B1ML2026-07-09
E235DD16B1MN0DENTADISCDD16B1MNDD16B1MN2026-07-09
E235DD16B2MN0DENTADISCDD16B2MNDD16B2MN2026-07-09
E235DD16B3MN0DENTADISCDD16B3MNDD16B3MN2026-07-09
E235DD16BL1MN0DENTADISCDD16BL1MNDD16BL1MN2026-07-09
E235DD16BL2MN0DENTADISCDD16BL2MNDD16BL2MN2026-07-09
E235DD16BL3ML0DENTADISCDD16BL3MLDD16BL3ML2026-07-09
E235DD16BL4MN0DENTADISCDD16BL4MNDD16BL4MN2026-07-09
E235DD16BLML0DENTADISCDD16BLMLDD16BLML2026-07-09
E235DD16BLMN0DENTADISCDD16BLMNDD16BLMN2026-07-09
E235DD16C1ML0DENTADISCDD16C1MLDD16C1ML2026-07-09
E235DD16C1MN0DENTADISCDD16C1MNDD16C1MN2026-07-09
E235DD16C2ML0DENTADISCDD16C2MLDD16C2ML2026-07-09
E235DD16C2MN0DENTADISCDD16C2MNDD16C2MN2026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
EJOT1410JOTAJota AGEJL2026-07-10
D661R100699C1AlpenCOLTENE/WHALEDENT INCEJL2026-06-05
D8120513291BUSCH®, BNA®BUSCH & CO. GmbH & Co. KGEJL2026-06-01
D8120513301BUSCH®, BNA®BUSCH & CO. GmbH & Co. KGEJL2026-06-01
00887919170488Brasseler USA Sterile CarbidePeter Brasseler Holdings, LLCEJL2026-05-27
07908611200822TUNGSTEN CARBIDE CUTTING BUR CC136FX LOW SPEED - 1UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJL2026-05-27
08404535030006Brasseler USA Sterile CarbidePeter Brasseler Holdings, LLCEJL2026-05-27
08404535030037Brasseler USA Sterile CarbidePeter Brasseler Holdings, LLCEJL2026-05-27
08435389830436EXTRA SHORT DRILL; Ø3.5 MMBIOTECHNOLOGY INSTITUTE SLEJL2026-05-27
08435389830542FLATTENING FRONT CUTTING DRILL; Ø3.1BIOTECHNOLOGY INSTITUTE SLEJL2026-05-27
08435389830559FLATTENING FRONT CUTTING SHORT DRILL; Ø3.1BIOTECHNOLOGY INSTITUTE SLEJL2026-05-27
08435389831266FLATTENING FRONT CUTTING DRILL, Ø4.1 INTERNA 3.0BIOTECHNOLOGY INSTITUTE SLEJL2026-05-27
ESUNC1623160165Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2025-04-29
ESUNC283K3140165Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-25
ESUNC33L3140105Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNC33L3140125Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNCC11040185Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNCC11040215Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNCC11040235Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNCC11040275Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNCTR323140125Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNTC1S2040125Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNTC1S2040145Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNTC1S2040165Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNTC1S2040215Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNTC1S2040235Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNC463140145Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-07
ESUNC463140185Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-07
ESUNC48L3140105Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-07
ESUNC48L3140125Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-07