FDA.reportPublic FDA data

DCI

Primary DI
00810021435718
Brand
DCI
Company
DCI International, LLC
Model
5364
Catalog number
5364
Device description
Precision Comfort Assistant's Package, 2 HVE, SE, SYR
Published
2024-05-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00810021435718PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810021435718008100214357188100214357180810021435718

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810021439532DCI Edge42856G2026-03-23
00810021439549DCI Edge42856W2026-03-23
00810021439556DCI Edge42857G2026-03-23
00810021439563DCI Edge42857W2026-03-23
00810021439570DCI Edge52893G2026-03-23
00810021439587DCI Edge52893W2026-03-23
00810021439594DCI Edge52906G2026-03-23
00810021439600DCI Edge52906W2026-03-23
00810021439617DCI EdgeDO57562026-03-23
00810021439518DCI Parts4404L2026-03-20
00810021439525DCI Parts4404R2026-03-20
00810021436791DCI Edge420432025-12-15
00810021437835DCI EdgePJT13852025-08-11
00810021436876DCI EdgeDS5051+2025-02-24
00810021436883DCI EdgeDS5550+2025-02-24
00810021436937DCI EdgeDS5551+2025-02-24
00810021436944DCI EdgeDO5650+2025-02-24
00810021437019DCI EdgeDO5550+2025-02-24
00810021437026DCI EdgeDO5050+2025-02-24
00810021437033DCI EdgeDO5150+2025-02-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810021439532DCI EdgeDCI International, LLCEIA2026-03-23
00810021439549DCI EdgeDCI International, LLCEIA2026-03-23
00810021439556DCI EdgeDCI International, LLCEIA2026-03-23
00810021439563DCI EdgeDCI International, LLCEIA2026-03-23
00810021439570DCI EdgeDCI International, LLCEIA2026-03-23
00810021439587DCI EdgeDCI International, LLCEIA2026-03-23
00810021439594DCI EdgeDCI International, LLCEIA2026-03-23
00810021439600DCI EdgeDCI International, LLCEIA2026-03-23
00810021439617DCI EdgeDCI International, LLCEIA2026-03-23
00810021439518DCI PartsDCI International, LLCEIA2026-03-20
00810021439525DCI PartsDCI International, LLCEIA2026-03-20
00841709122132MidmarkMIDMARK CORPORATIONEIA2026-03-11
00841709122149MidmarkMIDMARK CORPORATIONEIA2026-03-11
00841709122156MidmarkMIDMARK CORPORATIONEIA2026-03-11
00841709122163MidmarkMIDMARK CORPORATIONEIA2026-03-11
00841709122170MidmarkMIDMARK CORPORATIONEIA2026-03-11
00841709121852MidmarkMIDMARK CORPORATIONEIA2026-02-20
00841709121869MidmarkMIDMARK CORPORATIONEIA2026-02-20
00841709121876MidmarkMIDMARK CORPORATIONEIA2026-02-20
00841709121883MidmarkMIDMARK CORPORATIONEIA2026-02-20
10194665008697A-decA-DEC, INC.EIA2026-02-17
E27668302980Midwest Power Lux Implant MotorSIRONA Dental Systems GmbHEIA2026-02-13
E27668303060Midwest Power Lux MotorSIRONA Dental Systems GmbHEIA2026-02-13
00850043433521E300 Delivery SystemEngle Dental Systems, LLCEIA2026-02-09
00810208581269NuCareNuCare LLCECB2026-02-03
10810208581266NuCareNuCare LLCECB2026-02-03
20810208581263NuCareNuCare LLCECB2026-02-03
07899581342707Delivery UnitAlliage S/A Indústrias Médico OdontológicaEIA2025-12-31
07899581342844Delivery UnitAlliage S/A Indústrias Médico OdontológicaEIA2025-12-31
07899581343186Delivery UnitAlliage S/A Indústrias Médico OdontológicaEIA2025-12-31