FDA.reportPublic FDA data

MICD

Primary DI
E235284530
Brand
MICD
Company
SHOFU DENTAL CORPORATION
Model
28453
Catalog number
28453
Device description
MICD INSTRUMENT NO. 3
Published
2021-02-10
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
DZNInstruments, Dental Hand

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZNInstruments, Dental HandDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E235284530PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental material application tool, reusableA hand-held manual dental instrument intended to be used for the application of a dental material (e.g., composite resin) to a dental prosthesis or to a patient’s tooth/teeth; the material is not included. It includes a handle with an application tip which holds the material on its surface; it is not a syringe- or pistol-like device. 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
10860013564701CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564718CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564725CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564732CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564756CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564763CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564770CurvaGc Orthodontics America Inc.DZN2026-05-28
07898488905190INSTRUMENT FOR ICERAM SLB BRACKETORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZN2026-05-27
07908611211187CERAMIC NANO TUBE TWEEZERORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZN2026-05-27
07908611211255CURVERD SCISSORS FOR ALIGNERSORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZN2026-05-27
G149TBSB7500TBS BASICSACME ENTERPRISE.DZN2026-05-21
G149TBSB7510TBS BASICSACME ENTERPRISE.DZN2026-05-21
G149TBSB7520TBS BASICSACME ENTERPRISE.DZN2026-05-21
G149TBSB7530TBS BASICSACME ENTERPRISE.DZN2026-05-21
08404535018929Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535018950Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535019049Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535019070Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535019131Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535019162Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
07908854000647Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854000654Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854000661Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854000678Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854000838Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854000883Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854000890Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854001040Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854001071Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854001163Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22