FDA.reportPublic FDA data

Stabident

Primary DI
05060489370129
Brand
Stabident
Company
FAIRFAX MEDICAL PRODUCTS LIMITED
Model
Stabident Economy kit
Catalog number
SD
Device description
Dental anaesthesia injection kit.
Published
2023-06-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZMNeedle, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZMNeedle, DentalDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K910446000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K910446000STABIDENT LOCAL ANESTHESIA SYSTEMFairfax Dental, Inc.1991-06-03DZM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060489370129PrimaryGS10
05060489370150Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060489370129050604893701295060489370129
05060489370150050604893701505060489370150

GMDN Terms#

Term, Definition table
TermDefinition
Dental anaesthesia injection kitA collection of sterile devices designed to inject dental anaesthetics into gingival tissue or the oral mucosa, while preventing or reducing the risk of accidental needle-stick injury, during restorative or surgical dental procedures. It typically includes a syringe, a needle, a needle protection mechanism, and a plunger. This device does not contain the pharmaceuticals which are typically held within a cartridge produced to fit the syringe. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+442089476464info@stabident.com

Regulatory Flags#

DUNS number
227221793
Device count
100
DM exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060489370136Stabident Stabident Standard kit ST2023-06-08
05060489370006StabilokEconomy YellowJY2023-04-16
05060489370020StabilokEconomy BlueJB2023-04-16
05060489370167Stabident Stabident Standard kit ST2023-06-08
05060489370013StabilokEconomy Orange JO2023-04-16
05060489370037StabilokEconomy GreenJG2023-04-16
05060489370044StabilokStandard yellow SY2023-04-16
05060489370068StabilokStandard Blue SB2023-04-16
05060489370075StabilokStandard Green SG2023-04-16
05060489370082Stabilok drillDrill Yellow DY2023-04-16
05060489370099Stabilok drillDrill Orange DO2023-04-16
05060489370105Stabilok drillDrill BlueDB2023-04-16
05060489370112Stabilok drillDrill Green DG2023-04-16
00560489370020StabilokEconomy BlueJB2023-04-16
05060489370181StabilokEconomy Orange JO2023-04-16
05060489370174StabilokStandard yellow SY2023-04-16
05060489370051StabilokStandard Orange SO2023-04-16
00560489370174Stabilok drillDrill Yellow DY2023-04-16
00560489370181Stabilok drillDrill Orange DO2023-04-16
05060489370204Stabilok drillDrill BlueDB2023-04-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973042242834Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-10
06973042242841Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-10
06973042242865Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-10
06973042242872Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-10
06973042242889Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-10
06973042242896Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-10
06973042242902Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-10
06973042242919Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-10
06973042242926Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-10
06973042242933Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-10
06973042242940Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-10
06973042242957Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-10
06973042242964Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-10
06973042242971Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-10
06973042242988Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-10
06973042242674Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-09
06973042242681Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-09
06973042242698Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-09
06973042242704Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-09
06973042242711Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-09
06973042242728Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-09
06973042242735Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-09
06973042242742Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-09
06973042242759Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-09
06973042242766Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-09
06973042242780Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-09
06973042242797Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-09
06973042242803Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-09
06973042242810Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-09
06973042242827Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-09