FDA.report

Advance Dental Products

Primary DI
00371347005233
Brand
Advance Dental Products
Company
The Atlanta Dental Supply Company
Model
551003
Device description
Advance Basic Disposable Prophy Angles Firm
Published
2023-04-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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

Premarket Submissions

SubmissionSupplement
K103157000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K103157000DISPOSABLE PROPHY ANGLE; DISPOSABLE PROPHY ANGLEAngstrom Mfg., Inc.2011-01-24EGS

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00371347005233PrimaryGS10
20371347005237Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00371347005233003713470052333713470052330371347005233
2037134700523720371347005237

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
033505389
Device count
100
DM exempt
false
Premarket exempt
false
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
true
Sterilization required before use
false

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