FDA.report

Advance Dental Products

Primary DI
00371347009019
Brand
Advance Dental Products
Company
The Atlanta Dental Supply Company
Model
GP4T60A
Device description
Gutta Percha .04 Taper #60 Pkg/60
Published
2023-12-06
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
EKMGUTTA-PERCHA

Product Code Classifications

CodeDeviceSpecialtyClass
EKMGutta-PerchaDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10371347009016PrimaryGS10
00371347009019Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1037134700901610371347009016
00371347009019003713470090193713470090190371347009019

GMDN Terms

TermDefinition
Synthetic gutta-perchaA dental material made from a polymer-based, synthetic gutta-percha containing fillers and radiopacifiers in a soft resin matrix, intended to fill the root canal of a tooth. This material has the ability to resist leakage significantly better than natural gutta-percha based obturation whilst strengthening the root resulting in roots having a coronal and apical seal as part of the canal filling process. After application, this device cannot be reused.

Sterilization Methods

Method

Regulatory Flags

DUNS number
033505389
Device count
60
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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

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