FDA.report

Advance Dental Products

Primary DI
10371347005162
Brand
Advance Dental Products
Company
The Atlanta Dental Supply Company
Model
316137-28
Device description
Advance 3cc luer lock syringe w/27ga Slotted End/Side Vent tip
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
KXRAPPLICATOR, RESIN

Product Code Classifications

CodeDeviceSpecialtyClass
KXRApplicator, ResinDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00371347005165PrimaryGS10
10371347005162Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00371347005165003713470051653713470051650371347005165
1037134700516210371347005162

GMDN Terms

TermDefinition
Dental material injection cannula, single-useA rigid or semi-rigid luminal device (dental tip) intended to channel and dispense a dental material/solution [e.g., restorative amalgam, resin, etching solution (etchant), topical dental anaesthetic] from a dental syringe, or similar applicator, to a patient’s teeth, oral mucosa, or gums; it is not intended to penetrate tissue (it is not a needle), not dedicated to root canal irrigation, and may be used for dental applications outside the patients mouth. 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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00371347021172Advance Dental ProductsAPT1212026-01-15
00371347021189Advance Dental ProductsAPT1242026-01-15
00371347021196Advance Dental ProductsAPT1252026-01-15

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