FDA.report

Advance Dental Products

Primary DI
10371347005124
Brand
Advance Dental Products
Company
The Atlanta Dental Supply Company
Model
315623-28
Device description
Advance Endo Irrigation Needles Safe End/Side Port 23ga
Published
2023-02-10
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

Related Records

Product Codes

CodeName
EICSYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING

Product Code Classifications

CodeDeviceSpecialtyClass
EICSyringe, Periodontic, Endodontic, IrrigatingDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00371347005127PrimaryGS10
10371347005124Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00371347005127003713470051273713470051270371347005127
1037134700512410371347005124

GMDN Terms

TermDefinition
Root canal irrigation blunt needleA slender, hollow, tubular, metal instrument with a blunt tip designed specifically for irrigation of the root canal of a tooth during an endodontic procedure. Sometimes referred to as a root canal irrigation cannula, it is typically attached to a dental syringe (not included) filled with a root canal cleaning solution. It might be bent or straight and might have either a side vented tip or a blunt open-ended tip. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
033505389
Device count
100
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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