FDA.report

Henry Schein

Primary DI
00304040128503
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
1018780
Catalog number
1018780
Device description
Burnisher DE 21B
Published
2020-08-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EKJBURNISHER, OPERATIVE

Product Code Classifications

CodeDeviceSpecialtyClass
EKJBurnisher, OperativeDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00304040128503PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00304040128503003040401285033040401285030304040128503

GMDN Terms

TermDefinition
Manual dental burnisher, reusableA hand-held manual dental device with a smooth or ribbed working head intended to be used to create thin margins between a dental restoration and the enamel at the cavo-surface angle, and/or to polish the surface of metallic restorations by rubbing. Its terminus is round or ball-shaped and is typically made of metal. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
012430880
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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Other Devices Sharing Product Codes

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00840018672314Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKJ2026-02-10
00840018665729Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKJ2026-02-09
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