FDA.reportPublic FDA data

Aurora™

Primary DI
M595D6750
Brand
Aurora™
Company
PARKELL, INC.
Model
D675
Catalog number
D675
Device description
Aluminum Oxide (50micron) 5 Lbs.
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KOJAirbrush

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KOJAirbrushDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M595D6750PrimaryHIBCC0

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
PhoneEmail
6312491134customerservice@parkell.com

Regulatory Flags#

DUNS number
009900424
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M595S367UD1Epic®S367UDS367UD2016-09-23
M595S4130NAS413S4132016-09-23
00810000529568TotalBond®S413S4132018-11-23
00810000522729GentleCLEAN™DSG30GCPDSG30GCP2018-11-02
10810000527554Parkell®S276S2762018-10-19
M595S3930NAS393S3932016-09-23
M595S3940NAS394S3942016-09-23
M595S3950C&B METABOND®S395S3952016-09-23
00810000529070C&B METABOND®S394S3942018-11-23
00810000529193C&B METABOND®S393S3932018-11-23
00810000529209C&B METABOND®S395S3952018-11-23
00810000525294SmarTemp®S338S3382018-10-26
1081000052669420/20™S575S5752025-09-26
00810000525782HyperFIL®S235SPS235SP2025-09-26
00810000528271TriPhasix™S408S4082025-09-26
0081000052669720/20™S575S5752025-09-26
00810000520053Parkell®D675D6752018-11-16
00810000522934DuraTip®DURA30-PSLDURA30-PSL2025-07-18
00810000522941DuraTip®DURA30-PSRDURA30-PSR2025-07-18
00810000525751HyperFIL®S236S2362025-03-28

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