FDA.report

Henry Schein

Primary DI
00304040113745
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
1125759
Catalog number
1125759
Device description
Maestro Silicone Acrylic Kit Polishing Ea
Published
2019-08-13
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
EHLPOINT, ABRASIVE

Product Code Classifications

CodeDeviceSpecialtyClass
EHLPoint, AbrasiveDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00304040113745PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00304040113745003040401137453040401137450304040113745

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
012430880
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
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
false
Sterilization required before use
false

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