FDA.report

DCI

Primary DI
00810021437446
Brand
DCI
Company
DCI International, LLC
Model
ACU
Catalog number
4378
Device description
Arm Mounted Automatic Control Unit for 3 HP, Surf, to fit A-dec Cascade
Published
2024-03-11
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

Related Records

Contact Domains

Product Codes

CodeName
EIAUnit, Operative Dental

Product Code Classifications

CodeDeviceSpecialtyClass
EIAUnit, Operative DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810021437446PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810021437446008100214374468100214374460810021437446

GMDN Terms

TermDefinition
Dental delivery system instrument unit, pneumaticA pneumatically-powered device designed to make available the necessary instruments/equipment and power to deliver dental treatment to a patient. It consists of a platform for the display of a selection of powered dental instruments (e.g., motor handpiece, scaler, suction, air/water spray), sometimes with a control panel for setting various operating parameters; it may be portable or mounted. The device is commonly referred to as a dental unit or dental operative unit and is intended to be operated by a healthcare professional in a medical facility.

Sterilization Methods

Method

Contacts

PhoneEmail
5035372445regulatory@dcionline.com

Regulatory Flags

DUNS number
032221423
Device count
1
DM exempt
false
Premarket exempt
false
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
false

Other Devices From This Company

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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 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
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
07899581343414Delivery UnitAlliage S/A Indústrias Médico OdontológicaEIA2025-12-31
07899581343599Delivery UnitAlliage S/A Indústrias Médico OdontológicaEIA2025-12-31
07899581343834Water UnitAlliage S/A Indústrias Médico OdontológicaEIA2025-12-31