FDA.reportPublic FDA data

DCI Edge

Primary DI
00810021435565
Brand
DCI Edge
Company
DCI International, LLC
Model
DS5050+
Device description
Series 5 Plus Swing Mount Auto Dental Unit and Light Pole for Non-DCI Chairs
Published
2025-02-24
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250473000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250473000Dental Delivery System Series 5 and Dental Delivery System Series 5 PlusDci International, LLC2025-02-19EIA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810021435565PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810021435565008100214355658100214355650810021435565

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
5035372445regulatory@dcionlnine.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
00841709109805MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709109812MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709109843MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709109850MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709109874MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709109881MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709110030MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709110054MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709110061MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709111846MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709111853MidmarkMIDMARK CORPORATIONEIA2026-09-28
D955IRRTIP1Paul BandittTerlain Enterprises, Inc.EHZ2026-09-25
D955SUCKO1Paul BandittTerlain Enterprises, Inc.EHZ2026-09-25
D955SUCKOT1Paul BandittTerlain Enterprises, Inc.EHZ2026-09-25
D955SUCKOTS1Paul BandittTerlain Enterprises, Inc.EHZ2026-09-25
D955SUCKOWT1Paul BandittTerlain Enterprises, Inc.EHZ2026-09-25
00810194403187AiraAIRA, LLCEHZ2026-08-26
00810194403231AiraAIRA, LLCEHZ2026-08-26
00810194403248AiraAIRA, LLCEHZ2026-08-26
00850043433521E300 Delivery SystemEngle Dental Systems, LLCEIA2026-02-09
00850043433514E300 Dr./Asst Rear DeliveryEngle Dental Systems, LLCEIA2025-08-26
00814005020006TAQUALITY ASPIRATORS, INC.EHZ2025-02-27
0081400502001315P2-90AQUALITY ASPIRATORS, INC.EHZ2025-02-27
0081400502003703BATQUALITY ASPIRATORS, INC.EHZ2025-02-27
0081400502005115P3AQUALITY ASPIRATORS, INC.EHZ2025-02-27
0081400502006803BAQUALITY ASPIRATORS, INC.EHZ2025-02-27
0081400502008202BAQUALITY ASPIRATORS, INC.EHZ2025-02-27
0081400502009946P3MQUALITY ASPIRATORS, INC.EHZ2025-02-27
0081400502010515P2ATQUALITY ASPIRATORS, INC.EHZ2025-02-27
0081400502013615P2AQUALITY ASPIRATORS, INC.EHZ2025-02-27