FDA.reportPublic FDA data

Astek

Primary DI
20840326422032
Brand
Astek
Company
Young Innovations, Inc.
Model
116237ASTEK
Catalog number
116237ASTEK
Device description
Sirona Sprayvit SE137 Pro-Tip Converter Kit
Published
2023-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

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
10840326422035PackageGS11In Commercial Distribution
20840326422032PackageGS11In Commercial Distribution
00840326422038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084032642203510840326422035
2084032642203220840326422032
00840326422038008403264220388403264220380840326422038

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

Contacts#

Phone, Email table
PhoneEmail
+1(800) 558-6684support@youngspecialties.com

Regulatory Flags#

DUNS number
004193103
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10840326426200Young Specialties2000-02-102000-02-102026-01-26
10840326426217Young Specialties2000-03-102000-03-102026-01-26
10840326426224Young Specialties2000-04-102000-04-102026-01-26
10840326426231Young Specialties2000-05-102000-05-102026-01-26
10840326426248Young Specialties2000-06-102000-06-102026-01-26
10840326426255Young Specialties2000-07-102000-07-102026-01-26
10840326426262Young Specialties2000-08-102000-08-102026-01-26
10840326426279Young Specialties2000-09-102000-09-102026-01-26
10840326426286Young Specialties2000-10-102000-10-102026-01-26
10840326426293Young Specialties2000-15-102000-15-102026-01-26
00840326426302Young Specialties2000-16-102000-16-102026-01-26
10840326426316Young Specialties2000-17-102000-17-102026-01-26
10840326426323Young Specialties2000-18-102000-18-102026-01-26
10840326426330Young Specialties2000-19-102000-19-102026-01-26
10840326426347Young Specialties2000-20-102000-20-102026-01-26
10840326426354Young Specialties2000-21-102000-21-102026-01-26
10840326426361Young Specialties2000-22-102000-22-102026-01-26
10840326426378Young Specialties2000-23-102000-23-102026-01-26
10840326426385Young Specialties2000-24-102000-24-102026-01-26
10840326426392Young Specialties2000-25-102000-25-102026-01-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810208581269NuCareNuCare LLCECB2026-02-03
10810208581266NuCareNuCare LLCECB2026-02-03
20810208581263NuCareNuCare LLCECB2026-02-03
E89627160SCHWERTA. Schweickhardt GmbH & Co. KGECB2025-04-07
03760243009907Classic by RISKONTROLPRODUITS DENTAIRES PIERRE ROLLANECB2025-04-01
10840326423674AstekYoung Innovations, Inc.ECB2025-02-07
00810021436722DCIDCI International, LLCECB2024-12-13
00810021436739DCIDCI International, LLCECB2024-12-13
00810021436746DCIDCI International, LLCECB2024-12-13
00850048528864Amtouch Air/Water Syringe TipsAMERICAN MEDICAL & HOSPITAL SUPPLY CO., INC.ECB2024-10-08
00850048528901Amtouch Air/Water Syringe TipsAMERICAN MEDICAL & HOSPITAL SUPPLY CO., INC.ECB2024-10-08
00850048528918Amtouch Air/Water Syringe TipsAMERICAN MEDICAL & HOSPITAL SUPPLY CO., INC.ECB2024-10-08
00810021433783DCIDCI International, LLCECB2024-08-02
D930205010020JMUJMU DENTAL, INCECB2024-06-27
00810021435947DCIDCI International, LLCECB2024-05-24
20810021435958DCIDCI International, LLCECB2024-05-24
D248B1619B0DurationHAGER WORLDWIDE, INC.ECB2024-05-20
D248B16280Uni-TipHAGER WORLDWIDE, INC.ECB2024-05-20
E8962702090SCHWERTA. Schweickhardt GmbH & Co. KGECB2024-05-16
00810021434216DCIDCI International, LLCECB2024-05-13
00810021435466DCIDCI International, LLCECB2024-05-13
00810021435534DCIDCI International, LLCECB2024-05-13
00810021435541DCIDCI International, LLCECB2024-05-13
00810021435589DCIDCI International, LLCECB2024-05-13
00810021435602DCIDCI International, LLCECB2024-05-13
00810021435633DCIDCI International, LLCECB2024-05-13
00810021435640DCIDCI International, LLCECB2024-05-13
00810021435664DCIDCI International, LLCECB2024-05-13
00810021435671DCIDCI International, LLCECB2024-05-13
00810021435688DCIDCI International, LLCECB2024-05-13