FDA.reportPublic FDA data

A-dec

Primary DI
20194665001978
Brand
A-dec
Company
A-DEC, INC.
Model
23.0872.00
Catalog number
23.0872.00
Device description
Syringe Tip,Laser Etch
Published
2022-08-15
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

Product Codes#

Code, Name table
CodeName
ECBUnit, Syringe, Air And/Or Water

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECBUnit, Syringe, Air And/Or WaterDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K931137000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K931137000DENTAL SYRINGE TIPA-Dec, Inc.1993-11-29ECB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20194665001978PackageGS12In Commercial Distribution
30194665001975PackageGS15In Commercial Distribution
40194665001972PackageGS125In Commercial Distribution
10194665001971PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019466500197820194665001978
3019466500197530194665001975
4019466500197240194665001972
1019466500197110194665001971

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

Regulatory Flags#

DUNS number
009617473
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
10194665008918A-dec397pb397pb2026-06-22
10194665008857A-decS76S762026-05-07
10194665008444A-dec54.0924.0154.0924.012026-02-19
10194665008475A-dec54.1073.0054.1073.002026-02-19
10194665008482A-dec54.1073.0154.1073.012026-02-19
10194665008499A-dec54.1074.0054.1074.002026-02-19
10194665008505A-dec54.1074.0154.1074.012026-02-19
10194665008512A-dec54.1051.0054.1051.002026-02-19
10194665008529A-dec54.1052.0054.1052.002026-02-19
10194665008550A-dec54.1076.0054.1076.002026-02-19
10194665004460A-dec54.0865.0054.0865.002022-11-07
10194665008697A-dec3453452026-02-17
10194665008666A-decAMDUWLAMDUWL2025-09-30
10194665008383A-dec311xlc311xlc2025-09-18
10194665006587A-dec311FLT311FLT2025-05-19
10194665006594A-dec511FLT511FLT2025-05-19
10194665007935ActeonC202025-05-15
10194665008321A-decNo Version or Model Number54.1042.002025-05-15
10194665008345A-decNo Version or Model Number54.1043.002025-05-15
10194665007928A-dec 54.1041.0054.1041.002025-02-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810230800116DCI PartsDCI International, LLCECB2026-06-26
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00810230800147DCI PartsDCI International, LLCECB2026-06-26
00810230800154DCI PartsDCI International, LLCECB2026-06-26
00810230800161DCI PartsDCI International, LLCECB2026-06-26
00810230800178DCI PartsDCI International, LLCECB2026-06-26
00810230800185DCI PartsDCI International, LLCECB2026-06-26
00810230800192DCI PartsDCI International, LLCECB2026-06-26
00810230800208DCI PartsDCI International, LLCECB2026-06-26
00810230800215DCI PartsDCI International, LLCECB2026-06-26
00810230800222DCI PartsDCI International, LLCECB2026-06-26
00810230800239DCI PartsDCI International, LLCECB2026-06-26
00810230800246DCI PartsDCI International, LLCECB2026-06-26
00810230800253DCI PartsDCI International, LLCECB2026-06-26
00810230800260DCI PartsDCI International, LLCECB2026-06-26
00810230800277DCI PartsDCI International, LLCECB2026-06-26
00810230800284DCI PartsDCI International, LLCECB2026-06-26
00810230800291DCI PartsDCI International, LLCECB2026-06-26
00810230800307DCI PartsDCI International, LLCECB2026-06-26
00810230800314DCI PartsDCI International, LLCECB2026-06-26
00810230800321DCI PartsDCI International, LLCECB2026-06-26
00810230800338DCI PartsDCI International, LLCECB2026-06-26
00810230800345DCI PartsDCI International, LLCECB2026-06-26
00810230800352DCI PartsDCI International, LLCECB2026-06-26
00810230800369DCI PartsDCI International, LLCECB2026-06-26
00810230800376DCI PartsDCI International, LLCECB2026-06-26
00810230800383DCI PartsDCI International, LLCECB2026-06-26
00810230800390DCI PartsDCI International, LLCECB2026-06-26
00810230800406DCI PartsDCI International, LLCECB2026-06-26