FDA.report

DCI

Primary DI
00810021435688
Brand
DCI
Company
DCI International, LLC
Model
52906
Catalog number
50992
Device description
Telescoping Arm w/4 Position Holder, 1 Syringe, 1 HVE & 1 SE, Series 4
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

Related Records

Contact Domains

Product Codes

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

Product Code Classifications

CodeDeviceSpecialtyClass
ECBUnit, Syringe, Air And/Or WaterDental1
EIAUnit, Operative DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810021435688PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810021435688008100214356888100214356880810021435688

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

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

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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
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00841709121876MidmarkMIDMARK CORPORATIONEIA2026-02-20
00841709121883MidmarkMIDMARK CORPORATIONEIA2026-02-20
10194665008697A-decA-DEC, INC.EIA2026-02-17
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10810208581266NuCareNuCare LLCECB2026-02-03
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