FDA.reportPublic FDA data

DCI

Primary DI
00810021435541
Brand
DCI
Company
DCI International, LLC
Model
RM4
Catalog number
RM4651
Device description
Rear Cuspidor with Bowl Mounted Syringe, HVE and SE
Published
2024-05-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECBUnit, Syringe, Air And/Or WaterDental1
EIAUnit, Operative DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810021435541PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810021435541008100214355418100214355410810021435541

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
5035372445regulatory@dcionline.com

Regulatory Flags#

DUNS number
032221423
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810021435916DCI EdgeCP10002026-07-21
00810230800116DCI Parts343034232026-06-26
00810230800123DCI Parts343034242026-06-26
00810230800130DCI Parts343034252026-06-26
00810230800147DCI Parts343034282026-06-26
00810230800154DCI Parts343034292026-06-26
00810230800161DCI Parts343034362026-06-26
00810230800178DCI Parts343034372026-06-26
00810230800185DCI Parts343034382026-06-26
00810230800192DCI Parts343034392026-06-26
00810230800208DCI Parts343034402026-06-26
00810230800215DCI Parts343034412026-06-26
00810230800222DCI Parts343034432026-06-26
00810230800239DCI Parts343034432026-06-26
00810230800246DCI Parts343034442026-06-26
00810230800253DCI Parts343034452026-06-26
00810230800260DCI Parts343034462026-06-26
00810230800277DCI Parts343034472026-06-26
00810230800284DCI Parts343034522026-06-26
00810230800291DCI Parts343034532026-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810230800116DCI PartsDCI International, LLCECB2026-06-26
00810230800123DCI PartsDCI International, LLCECB2026-06-26
00810230800130DCI PartsDCI International, LLCECB2026-06-26
00810230800147DCI PartsDCI International, LLCECB2026-06-26
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