FDA.reportPublic FDA data

ADAPTATER RISKONTROL ADEC INOX

Primary DI
03760243000027
Brand
ADAPTATER RISKONTROL ADEC INOX
Company
ACTEON MANUFACTURING
Model
RISKONTROL
Catalog number
200195
Device description
The RISKONTROL adapter allows the use of the RISKONTROL disposable tips onto the air/water syringes.
Published
2024-03-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
ECBUnit, Syringe, Air And/Or Water

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECBUnit, Syringe, Air And/Or WaterDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760243000027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760243000027037602430000273760243000027

GMDN Terms#

Term, Definition table
TermDefinition
Dental delivery system irrigation handpieceA hand-held device that is used to regulate and direct a stream of pressurized, warmed water and/or air for the purpose of irrigating/clearing debris from the field of operation in the oral cavity during restorative or operative dental procedures. It is fitted with a long syringe-like nozzle that is activated by the user, typically through push-type controls. This device, also commonly known as a three-way or a Triplex syringe, is typically a component of a dental delivery system from which the air and water is supplied. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
283473691
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760243000430Art by RISKONTROLRISKONTROL2017002022-09-20
03760243000492Classic by RISKONTROLRISKONTROL2016642022-09-20
03760243000508Classic by RISKONTROLRISKONTROL2016652022-09-20
03760243000515Classic by RISKONTROLRISKONTROL2016662022-09-20
03760243000522Classic by RISKONTROLRISKONTROL2016672022-09-20
03760243000539Classic by RISKONTROLRISKONTROL2016682022-09-20
03760243000546Total protec by RISKONTROLRISKONTROL2017502022-09-20
03760243000706EXPASYL x20EXPASYL2610302022-09-20
03760243000713EXPASYL strawberry flavor EXPASYL2610012022-09-20
03760243000720Expasyl cannulasEXPASYL2610402022-09-20
03760243000737Expasyl cannulasEXPASYL2610052022-09-20
03760243000744Expasyl cannulasEXPASYL2610452022-09-20
03760243000751Expasyl cannulasEXPASYL2610152022-09-20
03760243001093Classic by RISKONTROLRISKONTROL2016692025-04-01
03760243005008EXPASYL x6EXPASYL2940102022-09-20
03760243000089ADAPTATER RISKONTROL DCIRISKONTROL2001522024-03-21
03760243000263ADAPTATER RISKONTROL LU INOXRISKONTROL2001502024-03-21
03760243000270ADAPTATER RISKONTROL LU NEW INOXRISKONTROL2001992024-03-21
03760243000553Total protec by RISKONTROLRISKONTROL2017512022-09-20
03760243000775 EXPASYLEXPASYL2941002022-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
30810021439403DCIDCI International, LLCECB2025-11-19
00840326423677AstekYoung Innovations, Inc.ECB2025-02-07
TQ26SYT253721Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.ECB2024-12-09
D248B16201DurationHAGER WORLDWIDE, INC.ECB2024-05-20
D248B16211DurationHAGER WORLDWIDE, INC.ECB2024-05-20
D248B1629C1Uni-TipHAGER WORLDWIDE, INC.ECB2024-05-20
00810339031176SAFE DENTBGSS Company Inc.ECB2024-05-01
00810339031251SAFE DENTBGSS Company Inc.ECB2024-05-01
00810339031374SAFE DENTBGSS Company Inc.ECB2024-05-01
00854014003577SAFE DENTBGSS Company Inc.ECB2024-05-01
00854014003607SAFE DENTBGSS Company Inc.ECB2024-05-01
00840326421994AstekYoung Innovations, Inc.ECB2023-12-01
00840326422007AstekYoung Innovations, Inc.ECB2023-12-01
00840326422014AstekYoung Innovations, Inc.ECB2023-12-01
00840326422021AstekYoung Innovations, Inc.ECB2023-12-01
00840326422045AstekYoung Innovations, Inc.ECB2023-12-01
00840326422052AstekYoung Innovations, Inc.ECB2023-12-01
00840326422069AstekYoung Innovations, Inc.ECB2023-12-01
00840326422076AstekYoung Innovations, Inc.ECB2023-12-01
00840326422083AstekYoung Innovations, Inc.ECB2023-12-01
00840326422090AstekYoung Innovations, Inc.ECB2023-12-01
00840326422106AstekYoung Innovations, Inc.ECB2023-12-01
00840326422113AstekYoung Innovations, Inc.ECB2023-12-01
D248B16291Uni-Tip -Package of 3HAGER WORLDWIDE, INC.ECB2023-09-12
D248B16311Access-Tips -Package of 3HAGER WORLDWIDE, INC.ECB2023-09-12
D248B16331Uni-Tip -Package of 100HAGER WORLDWIDE, INC.ECB2023-09-12
D248B16341Access-Tips -Package of 100HAGER WORLDWIDE, INC.ECB2023-09-12
D248B16351Uni-Tip -Package of 25HAGER WORLDWIDE, INC.ECB2023-09-12
D248B16361Access-Tips -Package of 25HAGER WORLDWIDE, INC.ECB2023-09-12
D248BOA124P10001Uni-Tip -Package of 5HAGER WORLDWIDE, INC.ECB2023-09-12