FDA.report

J & J INSTRUMENTS INC

Primary DI
00817524020694
Brand
J & J INSTRUMENTS INC
Company
J & J INSTRUMENTS INC
Model
02-510
Catalog number
02-510
Device description
BURNISHER DE #27/29
Published
2018-10-17
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
00817524020694PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00817524020694008175240206948175240206940817524020694

GMDN Terms

TermDefinition
Dental burnisherA rotary dental device with a smooth or ribbed working head used to create thin margins between a restoration and the enamel at the cavo-surface angle, and/or to polish the surface of metallic restorations by rubbing. It's terminus may be flat, ball, or beavertail. It is available according to the material used in the restoration (e.g., amalgam, gold alloy). This is a reusable device.

Device Sizes

TypeValueUnit
Length6.5Inch

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
783328149
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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