FDA.reportPublic FDA data

Stabident

Primary DI
05060489370136
Brand
Stabident
Company
FAIRFAX MEDICAL PRODUCTS LIMITED
Model
Stabident Standard kit
Catalog number
ST
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
DZADrill, Dental, Intraoral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZADrill, Dental, IntraoralDental1

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
05060489370136PrimaryGS10
05060489370167Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060489370136050604893701365060489370136
05060489370167050604893701675060489370167

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.

Contacts#

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

Regulatory Flags#

DUNS number
227221793
Device count
20
Kit
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060489370129Stabident Stabident Economy kit SD2023-06-08
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
07899878064985NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878064992NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065005NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065012NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065029NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065036NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065043NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065050NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065067NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065074NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065081NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065098NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065104NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065111NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
08056099233449VIVID POST DRILLBIOLOREN SRLDZA2024-03-21
07630049952607rootEX drill short shank 1,3 mm, pu: 6Diaswiss SADZA2023-10-02
07630049952614rootEX drill short shank 1,6 mm, pu: 6Diaswiss SADZA2023-10-02
07630049952621rootEX drill short shank 1,8 mm, pu: 6Diaswiss SADZA2023-10-02
07630049952683rootEX drill 0,8 mm, pu: 6 pcsDiaswiss SADZA2023-10-02
07630049952690rootEX drill 1,1 mm, pu: 6 pcsDiaswiss SADZA2023-10-02
07630049952706rootEX drill 1,3 mm, pu: 6 pcsDiaswiss SADZA2023-10-02
07630049952713rootEX drill 1,6 mm, pu: 6 pcsDiaswiss SADZA2023-10-02
07630049952720rootEX drill 1,8 mm, pu: 6 pcsDiaswiss SADZA2023-10-02
07630049952782rootEX plug short 1,0 mm, pu: 6 pcsDiaswiss SADZA2023-10-02
07630049952799rootEX plug short 1,3 mm pu: 6 pcsDiaswiss SADZA2023-10-02
07630049952805rootEX plug short 1,5 mm pu: 6 pcsDiaswiss SADZA2023-10-02
07630049952812rootEX plug short 1,8 mm pu: 6 pcsDiaswiss SADZA2023-10-02
07630049952829rootEX plug short 2,0 mm pu: 6 pcsDiaswiss SADZA2023-10-02
07630049952836rootEX plug 1,0 mm pu: 6 pcsDiaswiss SADZA2023-10-02
07630049952843rootEX plug 1,3 mm pu: 6 pcsDiaswiss SADZA2023-10-02