FDA.reportPublic FDA data

DCI

Primary DI
00810021434001
Brand
DCI
Company
DCI International, LLC
Model
5368
Device description
Standard Vacuum Package, 2 HVE, SE
Published
2024-05-15
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
EHZEvacuator, Oral Cavity
EIAUnit, Operative Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHZEvacuator, Oral CavityDental1
EIAUnit, Operative DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810021434001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810021434001008100214340018100214340010810021434001

GMDN Terms#

Term, Definition table
TermDefinition
Dental suction system cannula, reusableA semi-rigid or rigid hollow tubular component of a dental suction system designed to be inserted into the oral cavity for the aspiration and removal of blood, pus, saliva, debris, and water during a dental procedure. It is made of metal or plastic materials that can be sterilized. 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
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
00810230800307DCI Parts343034552026-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456202630JMUJMU DENTAL, INCEHZ2026-06-23
00840456202647JMUJMU DENTAL, INCEHZ2026-06-23
00840456209165JMUJMU DENTAL, INCEHZ2026-06-23
00840456209172JMUJMU DENTAL, INCEHZ2026-06-23
00840456209189JMUJMU DENTAL, INCEHZ2026-06-23
00840456216989JMUJMU DENTAL, INCEHZ2026-06-23
00840456216996JMUJMU DENTAL, INCEHZ2026-06-23
00840456218044JMUJMU DENTAL, INCEHZ2026-06-23
00840456218051JMUJMU DENTAL, INCEHZ2026-06-23
00840456218068JMUJMU DENTAL, INCEHZ2026-06-23
08800156000013ELEC MasterMGNEWTON Co. LTD.,EIA2026-04-30
07898971838004OlsenOlsen Indústria e Comércio S/AEIA2026-04-22
J00715021220011BOARD DMX3 M BornierBIEN-AIR PORTUGAL, UNIPESSOAL, LDAEIA2026-02-24
J00715021230011BOARD DMX3 M BtoBBIEN-AIR PORTUGAL, UNIPESSOAL, LDAEIA2026-02-24
10371347017790Advance Dental ProductsThe Atlanta Dental Supply CompanyEHZ2025-11-18
10371347017806Advance Dental ProductsThe Atlanta Dental Supply CompanyEHZ2025-11-18
10371347017813Advance Dental ProductsThe Atlanta Dental Supply CompanyEHZ2025-11-18
10371347017820Advance Dental ProductsThe Atlanta Dental Supply CompanyEHZ2025-11-18
J00716012590011Console Optima INTBien-Air Dental SAEIA2025-11-10
10080196553686MEDLINEMEDLINE INDUSTRIES, INC.EHZ2024-09-19
08800053083249Luvis Chair (LC700C)DENTIS CO. ,LTDEIA2024-09-19
J00716011960051IDUP boardBien-Air Dental SAEIA2023-09-11
J021303530001MC-2.0 I (Motorcontroller Implantology)W & H Dentalwerk Bürmoos GmbHEIA2023-07-19
J021303580001Perestaltic Pump W & H Dentalwerk Bürmoos GmbHEIA2023-07-19
J021303630001EXP-PD-ST-00 (Pump Controller)W & H Dentalwerk Bürmoos GmbHEIA2023-07-19
J021302780001MC-1.0 and AD-1.0 Analog MotorcontrollerW & H Dentalwerk Bürmoos GmbHEIA2023-07-11
H668D6401141PearsonKeystone IndustriesEHZ2023-02-20
H668D6401151PearsonKeystone IndustriesEHZ2023-02-20
H668D6401211PearsonKeystone IndustriesEHZ2023-02-20
H668D6401261PearsonKeystone IndustriesEHZ2023-02-20