FDA.reportPublic FDA data

Aira

Primary DI
00810194403330
Brand
Aira
Company
AIRA, LLC
Model
100629
Device description
Pre-Bent Applicator Tips 19g Black
Published
2026-08-25
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

Product Codes#

Code, Name table
CodeName
KXRApplicator, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXRApplicator, ResinDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810194403392PackageGS1500In Commercial Distribution
00810194403330PrimaryGS10
10810194403337Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810194403392008101944033928101944033920810194403392
00810194403330008101944033308101944033300810194403330
1081019440333710810194403337

GMDN Terms#

Term, Definition table
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.

Regulatory Flags#

DUNS number
137437162
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810194400766Aira1005962026-08-26
00810194401671Aira1002302026-08-26
00810194401909Aira6001002026-08-26
00810194401930Aira6001032026-08-26
00810194401947Aira6001042026-08-26
00810194401954Aira6001052026-08-26
00810194401961Aira6001062026-08-26
00810194402005Aira6001102026-08-26
00810194402029Aira6001122026-08-26
00810194402036Aira6001132026-08-26
00810194402074Aira6001172026-08-26
00810194402081Aira6001182026-08-26
00810194402111Aira6001212026-08-26
00810194402128Aira6001222026-08-26
00810194402135Aira6001232026-08-26
00810194402166Aira6001262026-08-26
00810194402319Aira6001412026-08-26
00810194402340Aira6001442026-08-26
00810194402357Aira6001452026-08-26
00810194402364Aira6001462026-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810194403293AiraAIRA, LLCKXR2026-08-25
00810194403309AiraAIRA, LLCKXR2026-08-25
00810194403323AiraAIRA, LLCKXR2026-08-25
00840456202555JMUJMU DENTAL, INCKXR2026-07-27
00840456202562JMUJMU DENTAL, INCKXR2026-07-27
00840456202579JMUJMU DENTAL, INCKXR2026-07-27
00840456202586JMUJMU DENTAL, INCKXR2026-07-27
00840456202593JMUJMU DENTAL, INCKXR2026-07-27
00840456218006JMUJMU DENTAL, INCKXR2026-07-27
00840456218013JMUJMU DENTAL, INCKXR2026-07-27
00840456218020JMUJMU DENTAL, INCKXR2026-07-27
00840456218037JMUJMU DENTAL, INCKXR2026-07-27
00840456202401JMUJMU DENTAL, INCKXR2026-07-08
00840456223222JMUJMU DENTAL, INCKXR2026-07-08
00840456223239JMUJMU DENTAL, INCKXR2026-07-08
D1257500B2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257500G2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257500L2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257500Y2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257501B2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257501G2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257501L2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257501Y2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257502T4Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257502W4Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257510B2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257510G2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257510L2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257510Y2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257511B2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21