FDA.report

MALIBU PINCUTTERS

Primary DI
D772ATI39202PC20
Brand
MALIBU PINCUTTERS
Company
AMERICAN TOOTH INDUSTRIES
Model
08-202 PC2
Device description
100 MALIBU PINCUTTERS 40MMX1MM
Published
2023-11-01
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
EHJDisk, Abrasive

Product Code Classifications

CodeDeviceSpecialtyClass
EHJDisk, AbrasiveDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D772ATI39202PC20PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental abrasive point, reusableA rotary endpiece designed to be attached to a dental power tool handpiece to produce an abrasive rotation typically for polishing and smoothing natural or restorative dental materials (e.g., crown) during a dental procedure. Also referred to as a polisher, it is available in various forms (e.g., conical), sizes, and materials [e.g., silicone, rubber, metal, diamond, silicon carbide, aluminium oxide]. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
161532999
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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