FDA.reportPublic FDA data

PWR Classic Powder

Primary DI
10889950143282
Brand
PWR Classic Powder
Company
HU-FRIEDY MFG. CO., LLC
Model
AP-CN
Device description
PWR Classic Powder - Neutral
Published
2024-09-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EJRAGENT, POLISHING, ABRASIVE, ORAL CAVITY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJRAgent, Polishing, Abrasive, Oral CavityDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889950143282PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088995014328210889950143282

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity70 Percent (%) Relative Humidity

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)483-7433info@hu-friedy.com

Regulatory Flags#

DUNS number
005085972
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800012410956Hu-FriedySSC-KIT2026-10-20
08800012411038Hu-FriedySSC-URD22026-10-20
08800012411182Hu-FriedySSC-LRD52026-10-20
08800012411199Hu-FriedySSC-LRD62026-10-20
08800012411205Hu-FriedySSC-LRD72026-10-20
08800012411212Hu-FriedySSC-ULE22026-10-20
08800012411229Hu-FriedySSC-ULE32026-10-20
08800012411236Hu-FriedySSC-ULE42026-10-20
08800012411243Hu-FriedySSC-ULE52026-10-20
08800012411250Hu-FriedySSC-ULE62026-10-20
08800012411267Hu-FriedySSC-ULE72026-10-20
08800012411397Hu-FriedySSC-LRE22026-10-20
08800012411403Hu-FriedySSC-LRE32026-10-20
08800012411410Hu-FriedySSC-LRE42026-10-20
08800012410970Hu-FriedySSC-ULD22024-10-14
08800012410987Hu-FriedySSC-ULD32024-10-14
08800012410994Hu-FriedySSC-ULD42024-10-14
08800012411014Hu-FriedySSC-ULD62024-10-14
08800012411021Hu-FriedySSC-ULD72024-10-14
08800012411045Hu-FriedySSC-URD32024-10-14

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