FDA.reportPublic FDA data

SAFE DENT

Primary DI
00810339031251
Brand
SAFE DENT
Company
BGSS Company Inc.
Model
A90125CW
Device description
A90125CW AIR WATER SYRINGE TIP (CLEAR/WHITE)
Published
2024-05-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
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
00810339031268PackageGS140In Commercial Distribution
00810339031251PrimaryGS10
00810339031244Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810339031268008103390312688103390312680810339031268
00810339031251008103390312518103390312510810339031251
00810339031244008103390312448103390312440810339031244

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.

Regulatory Flags#

DUNS number
828474952
Device count
250
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854014003263SAFE DENTC60112024-05-01
00854014003294SAFE DENTC60122024-05-01
00854014003331SAFE DENTC60132024-05-01
00854014003362SAFE DENTCF60142024-05-01
00810339030001SAFE DENTP50132024-05-01
00810339030032SAFE DENTP5016XL2024-05-01
00810339030063SAFE DENTP50102024-05-01
00810339030094SAFE DENTP50192024-05-15
00810339030124SAFE DENTP50142024-05-01
00810339030162SAFE DENTP5015XL2024-05-01
00810339030193SAFE DENTP50182024-05-01
00810339030483SAFE DENTB2010W2024-05-01
00810339030506SAFE DENTB2011BL2024-05-01
00810339030520SAFE DENTB2012DR2024-05-01
00810339030544SAFE DENTB2013MG2024-05-01
00810339030568SAFE DENTB2014LV2024-05-01
00810339030582SAFE DENTB2015P2024-05-01
00810339030605SAFE DENTB2016Y2024-05-01
00810339030926SAFE DENTBF90167C2024-05-01
00810339030957SAFE DENTBF90166B2024-05-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810230800116DCI PartsDCI International, LLCECB2026-06-26
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00810230800154DCI PartsDCI International, LLCECB2026-06-26
00810230800161DCI PartsDCI International, LLCECB2026-06-26
00810230800178DCI PartsDCI International, LLCECB2026-06-26
00810230800185DCI PartsDCI International, LLCECB2026-06-26
00810230800192DCI PartsDCI International, LLCECB2026-06-26
00810230800208DCI PartsDCI International, LLCECB2026-06-26
00810230800215DCI PartsDCI International, LLCECB2026-06-26
00810230800222DCI PartsDCI International, LLCECB2026-06-26
00810230800239DCI PartsDCI International, LLCECB2026-06-26
00810230800246DCI PartsDCI International, LLCECB2026-06-26
00810230800253DCI PartsDCI International, LLCECB2026-06-26
00810230800260DCI PartsDCI International, LLCECB2026-06-26
00810230800277DCI PartsDCI International, LLCECB2026-06-26
00810230800284DCI PartsDCI International, LLCECB2026-06-26
00810230800291DCI PartsDCI International, LLCECB2026-06-26
00810230800307DCI PartsDCI International, LLCECB2026-06-26
00810230800314DCI PartsDCI International, LLCECB2026-06-26
00810230800321DCI PartsDCI International, LLCECB2026-06-26
00810230800338DCI PartsDCI International, LLCECB2026-06-26
00810230800345DCI PartsDCI International, LLCECB2026-06-26
00810230800352DCI PartsDCI International, LLCECB2026-06-26
00810230800369DCI PartsDCI International, LLCECB2026-06-26
00810230800376DCI PartsDCI International, LLCECB2026-06-26
00810230800383DCI PartsDCI International, LLCECB2026-06-26
00810230800390DCI PartsDCI International, LLCECB2026-06-26
00810230800406DCI PartsDCI International, LLCECB2026-06-26