FDA.report

AllPro

Primary DI
00813360020003
Brand
AllPro
Company
TEAM TECHNOLOGIES, INC.
Model
800 DPA
Catalog number
800-100
Device description
DPA, Hot Pink Ultra Soft
Published
2022-07-24
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
true

Related Records

Product Codes

CodeName
EGSHandpiece, Contra- And Right-Angle Attachment, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
EGSHandpiece, Contra- And Right-Angle Attachment, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00813360020003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00813360020003008133600200038133600200030813360020003

GMDN Terms

TermDefinition
Dental polishing cup, single-useA rotational device, typically made from rubber material, that is used to apply polishing agents during dental prophylaxis (cleaning). Commonly known as a prophylaxis cup it is held in a dental handpiece, which rotates the cup at high speeds as the polishing agent is applied to the surface of the teeth. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
078550672
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
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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00813360023578DoselogixTC9-A-LIGHTSAFE 3.5ML Micro7556252024-08-13
00813360023585DoselogixTC9-A-LIGHTSAFE 6.5ML Micro7556262024-08-13
00813360023592DoselogixTC9-R-BLUE 3.5ML Micro7556272024-08-13
00813360023608DoselogixTC9-R-BLUE 6.5ML Micro7556282024-08-13
00813360023615DoselogixTC9-R-LIGHTSAFE 3.5ML Micro7556292024-08-13
00813360023622DoselogixTC9-R-LIGHTSAFE 6.5ML Micro7556302024-08-13
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