FDA.report

FG GINGICURETTAGE

Primary DI
E235C08210
Brand
FG GINGICURETTAGE
Company
SHOFU DENTAL CORPORATION
Model
C082-1
Catalog number
C082-1
Device description
FG GINGICURETTAGE
Published
2021-02-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
DZPINSTRUMENT, DIAMOND, DENTAL

Product Code Classifications

CodeDeviceSpecialtyClass
DZPInstrument, Diamond, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
E235C08210PrimaryHIBCC0

GMDN Terms

TermDefinition
Diamond dental bur, reusableA rotary cutting device made of high-grade steel with the working end coated with particles of diamond, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, such as teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials intended for use in the fabrication of dental devices. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)827-5262customer-service@shofu.com

Regulatory Flags

DUNS number
054618202
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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E235SIPR30SUPER-SNAP IPRSIPR3SIPR32026-03-05
E235SIPR40SUPER-SNAP IPRSIPR4SIPR42026-03-05
E235SIPR50SUPER-SNAP IPRSIPR5SIPR52026-03-05
E235SIPR60SUPER-SNAP IPRSIPR6SIPR62026-03-05
E235SIPR70SUPER-SNAP IPRSIPR7SIPR72026-03-05
E235SIPR80SUPER-SNAP IPRSIPR8SIPR82026-03-05
E235SIPR90SUPER-SNAP IPRSIPR9SIPR92026-03-05
E235DD18A1ML0DENTADISCDD18A1MLDD18A1ML2026-01-25
E235DD18A1MN0DENTADISCDD18A1MNDD18A1MN2026-01-25

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