FDA.reportPublic FDA data

CanalPro Color Syringes

Primary DI
16974843120168
Brand
CanalPro Color Syringes
Company
ZOGEAR Medical Co., Ltd.
Model
CanalPro Color Syringes (5 ml) yellow
Published
2023-04-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
EICSyringe, Periodontic, Endodontic, Irrigating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EICSyringe, Periodontic, Endodontic, IrrigatingDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26974843120165PackageGS124In Commercial Distribution
16974843120168PrimaryGS10
06974843120161Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2697484312016526974843120165
1697484312016816974843120168
06974843120161069748431201616974843120161

GMDN Terms#

Term, Definition table
TermDefinition
Dental impression material syringe, single-useA non-sterile, hand-held manual dental instrument designed to inject impression material into an impression tray or directly into a patient?s mouth. This is a single-use device.

Regulatory Flags#

DUNS number
710958353
Device count
50
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16974843120106CanalPro Color SyringesCanalPro Color Syringes (10 ml) red2023-04-20
16974843120113CanalPro Color SyringesCanalPro Color Syringes (10 ml) blue2023-04-20
16974843120120CanalPro Color SyringesCanalPro Color Syringes (10 ml) yellow2023-04-20
16974843120137CanalPro Color SyringesCanalPro Color Syringes (10 ml) white2023-04-20
16974843120144CanalPro Color SyringesCanalPro Color Syringes (5 ml) red2023-04-20
16974843120151CanalPro Color SyringesCanalPro Color Syringes (5 ml) blue2023-04-20
16974843120175CanalPro Color SyringesCanalPro Color Syringes (5 ml) white2023-04-20
26974843120103CanalPro Color SyringesCanalPro Color Syringes (10 ml) red2023-04-20
26974843120110CanalPro Color SyringesCanalPro Color Syringes (10 ml) blue2023-04-20
26974843120127CanalPro Color SyringesCanalPro Color Syringes (10 ml) yellow2023-04-20
26974843120134CanalPro Color SyringesCanalPro Color Syringes (10 ml) white2023-04-20
26974843120141CanalPro Color SyringesCanalPro Color Syringes (5 ml) red2023-04-20
26974843120158CanalPro Color SyringesCanalPro Color Syringes (5 ml) blue2023-04-20
26974843120165CanalPro Color SyringesCanalPro Color Syringes (5 ml) yellow2023-04-20
26974843120172CanalPro Color SyringesCanalPro Color Syringes (5 ml) white2023-04-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB71040TBS BASICSACME ENTERPRISE.EIC2026-05-22
00371347023466Advance Dental ProductsThe Atlanta Dental Supply CompanyEIC2026-04-14
00371347023473Advance Dental ProductsThe Atlanta Dental Supply CompanyEIC2026-04-14
G1493807003TBS DentalACME ENTERPRISE.EIC2026-03-02
00850014374983MARK3®CARGUS INTERNATIONAL, INCEIC2026-02-05
00850014374990MARK3®CARGUS INTERNATIONAL, INCEIC2026-02-05
00850440008339IrriGatorEngineered Endodontics, LLCEIC2026-01-02
00850440008346IrriGatorEngineered Endodontics, LLCEIC2026-01-02
00850440008353IrriGatorEngineered Endodontics, LLCEIC2026-01-02
00850440008360IrriGatorEngineered Endodontics, LLCEIC2026-01-02
00850440008377IrriGatorEngineered Endodontics, LLCEIC2026-01-02
00850440008384IrriGatorEngineered Endodontics, LLCEIC2026-01-02
00850440008391ES Cap TipsEngineered Endodontics, LLCEIC2026-01-02
00850440008513ES VacEngineered Endodontics, LLCEIC2026-01-02
00850440008520ES VacEngineered Endodontics, LLCEIC2026-01-02
00850440008537ES VacEngineered Endodontics, LLCEIC2026-01-02
00850440008551JS IrriGator Engineered Endodontics, LLCEIC2026-01-02
00850440008568JS IrriGator Engineered Endodontics, LLCEIC2026-01-02
00850440008575JS IrriGator Engineered Endodontics, LLCEIC2026-01-02
008504400086433DPD Paste Delivery TipEngineered Endodontics, LLCEIC2026-01-02
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00850440008667IrriGator Flex TipEngineered Endodontics, LLCEIC2026-01-02
00841336109438Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIC2025-11-11
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00810118106538Avalon Biomed Clear Flex Tips - 20 PackNUSMILE, LTD.EIC2025-07-15
00810118106545Avalon Biomed Clear Flex Tips - 40 PackNUSMILE, LTD.EIC2025-07-15
00883205033123NaviTip 29G SideportULTRADENT PRODUCTS, INC.EIC2025-03-11