FDA.reportPublic FDA data

Stabilok

Primary DI
05060489370037
Brand
Stabilok
Company
FAIRFAX MEDICAL PRODUCTS LIMITED
Model
Economy Green
Catalog number
JG
Device description
Intended use to anchor a dentine pin in tooth dentine prior to building up the tooth. 100 single use pins + 5 reusable drills
Published
2023-04-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBLPin, Retentive And Splinting, And Accessory Instruments

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBLPin, Retentive And Splinting, And Accessory InstrumentsDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060489370037PrimaryGS10
05060489370198Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060489370037050604893700375060489370037
05060489370198050604893701985060489370198

GMDN Terms#

Term, Definition table
TermDefinition
Dental restoration retention pinA device intended to be placed permanently in the tooth to provide retention and/or stabilization for a dental restoration (e.g., a filling or a crown). It is typically made of stainless steel or titanium (Ti) and comes in a variety of sizes (e.g., 1.0 mm to 3.2 mm). The device is inserted into a pre-drilled hole in the tooth and is secured by threading, friction and/or cementing.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter0.76Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
227221793
Device count
100
DM exempt
true
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060489370136Stabident Stabident Standard kit ST2023-06-08
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
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
00810060227046Blue Sky Bio, LLC.BLUE SKY BIO LLCEBL2026-02-10
00810060225967Blue Sky Bio, LLC.BLUE SKY BIO LLCEBL2024-05-29
00810060225974Blue Sky Bio, LLC.BLUE SKY BIO LLCEBL2024-05-29
00810060225981Blue Sky Bio, LLC.BLUE SKY BIO LLCEBL2024-05-29
00810060225998Blue Sky Bio, LLC.BLUE SKY BIO LLCEBL2024-05-29
00810060226001Blue Sky Bio, LLC.BLUE SKY BIO LLCEBL2024-05-29
00810060226018Blue Sky Bio, LLC.BLUE SKY BIO LLCEBL2024-05-29
00810060226025Blue Sky Bio, LLC.BLUE SKY BIO LLCEBL2024-05-29
00810060226032Blue Sky Bio, LLC.BLUE SKY BIO LLCEBL2024-05-29
08800075620965OSUNG MNDOSUNG MND Co., Ltd.EBL2024-03-06
08800075620972OSUNG MNDOSUNG MND Co., Ltd.EBL2024-03-06
00810060225721Blue Sky Bio, LLC.BLUE SKY BIO LLCEBL2023-11-09
05060489370006StabilokFAIRFAX MEDICAL PRODUCTS LIMITEDEBL2023-04-16
05060489370013StabilokFAIRFAX MEDICAL PRODUCTS LIMITEDEBL2023-04-16
05060489370044StabilokFAIRFAX MEDICAL PRODUCTS LIMITEDEBL2023-04-16
05060489370068StabilokFAIRFAX MEDICAL PRODUCTS LIMITEDEBL2023-04-16
05060489370075StabilokFAIRFAX MEDICAL PRODUCTS LIMITEDEBL2023-04-16
05060489370020StabilokFAIRFAX MEDICAL PRODUCTS LIMITEDEBL2023-04-16
00560489370020StabilokFAIRFAX MEDICAL PRODUCTS LIMITEDEBL2023-04-16
05060489370181StabilokFAIRFAX MEDICAL PRODUCTS LIMITEDEBL2023-04-16
05060489370174StabilokFAIRFAX MEDICAL PRODUCTS LIMITEDEBL2023-04-16
05060489370051StabilokFAIRFAX MEDICAL PRODUCTS LIMITEDEBL2023-04-16
05060489370204Stabilok drillFAIRFAX MEDICAL PRODUCTS LIMITEDEBL2023-04-16
05060489370198Stabilok drillFAIRFAX MEDICAL PRODUCTS LIMITEDEBL2023-04-16
D2483801802Markley Threaded Wire .018HAGER WORLDWIDE, INC.EBL2023-04-10
D248380220Markley Threaded Wire .022HAGER WORLDWIDE, INC.EBL2023-04-10
D2483802500Markley Threaded Wire .025HAGER WORLDWIDE, INC.EBL2023-04-10
D2483802702Markley Threaded Wire .027HAGER WORLDWIDE, INC.EBL2023-04-10
D248380300Markley Threaded Wire .030HAGER WORLDWIDE, INC.EBL2023-04-10
D248380320Markley Threaded Wire .032HAGER WORLDWIDE, INC.EBL2023-04-10