FDA.report

Henry Schein

Primary DI
00304040164280
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5703088
Catalog number
5703088
Device description
AIRPOLISHING POWDER. FRESH TASTING SODIUM BICARBONATE POWDER WITH MINT FLAVOR, FOR REMOVAL OF STAINS AND PLAQUE
Published
2022-06-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EJRAGENT, POLISHING, ABRASIVE, ORAL CAVITY

Product Code Classifications

CodeDeviceSpecialtyClass
EJRAgent, Polishing, Abrasive, Oral CavityDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00304040164280PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00304040164280003040401642803040401642800304040164280

GMDN Terms

TermDefinition
Dental abrasive powderA dental material made from various base substances having some abrasive qualities [e.g., treated sodium bicarbonate (NaHCO3) or aluminium oxide (Al2O3)] and applied with an appropriate device (e.g., a dental abrasive air jet system) to the surface of teeth or dental devices. It has a wide variety of both prophylactic and treatment applications such as the removal of plaque and stains, cleaning fissures (above and below the gingiva), the preparation of a tooth surface prior to bonding, the cleaning of orthodontic appliances (bands and brackets), the removal of adhesive residue, and the cleaning of implants prior to loading. This is a single-use device.

Sterilization Methods

Method

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
false

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