FDA.report

ONEGLOSS

Primary DI
E23504350
Brand
ONEGLOSS
Company
SHOFU DENTAL CORPORATION
Model
0435
Catalog number
0435
Device description
ONEGLOSS MANDREL CA
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
EJLBUR, DENTAL

Product Code Classifications

CodeDeviceSpecialtyClass
EJLBur, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
E23504350PrimaryHIBCC0

GMDN Terms

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
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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E2351001TP0TRINIA1001TP1001TP2026-03-06
E2351002T0TRINIA1002T1002T2026-03-06
E2351003T0TRINIA1003T1003T2026-03-06
E2351004T0TRINIA1004T1004T2026-03-06
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E235SIPR10SUPER-SNAP IPRSIPR1SIPR12026-03-05
E235SIPR20SUPER-SNAP IPRSIPR2SIPR22026-03-05
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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00810126508294Sabur by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEJL2026-03-11
00810126508300Sabur by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEJL2026-03-11
00810126508317Sabur by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEJL2026-03-11
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