FDA.reportPublic FDA data

PlastCare

Primary DI
D066PGS3CC30GKIT1
Brand
PlastCare
Company
Proguard Health, Inc
Model
PG-S3CC30G KIT
Catalog number
PG-S3CC30G KIT
Device description
Irrigation Needle With Half Cutting Tips: 30Cc Syringe + 30G
Published
2021-07-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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
D066PGS3CC30GKIT2PackageHIBCC20In Commercial Distribution
D066PGS3CC30GKIT1PrimaryHIBCC0
D066PGS3CC30GKIT0Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental irrigation/aspiration syringeA hand-held manual dental device (a plunger-type syringe) designed to inject and/or aspirate a volume of solution into the working area in the oral cavity. It typically consists of a small syringe (e.g., 3 ml) and is used for washing and aspirating the pulp cavity and root canal to remove debris. It is hand-operated by the user who exerts a steady pressure on, e.g., thumb rings and/or swivel finger bars, which exerts pressure on the syringe plunger forcing the washing/rinsing fluids through an attached needle (e.g., a blunt or very fine needle) directly at the operative site. This is a reusable device.

Regulatory Flags#

DUNS number
129529337
Device count
100
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D066PGMBK11PlastCarePG-MBK1PG-MBK12021-07-02
D066PGMBK21PlastCarePG-MBK2PG-MBK22021-07-02
D066PGMBK31PlastCarePG-MBK3PG-MBK32021-07-02
D066PGMBL11PlastCarePG-MBL1PG-MBL12021-07-02
D066PGMBL21PlastCarePG-MBL2PG-MBL22021-07-02
D066PGMBL31PlastCarePG-MBL3PG-MBL32021-07-02
D066PGMHL11HopePG-MHL1PG-MHL12021-07-02
D066PG30341PlastCarePG-3034PG-30342021-07-02
D066PG10161PlastCarePG-1016PG-10162021-07-02
D066PG12191PlastCarePG-1219PG-12192021-07-02
D066PG22041PlastCarePG-2204PG-22042021-07-02
D066PG23371PlastCarePG-2337PG-23372021-07-02
D066PG23501PlastCarePG-2350PG-23502021-07-02
D066PG23901PlastCarePG-2390PG-23902021-07-02
D066PG27101PlastCarePG-2710PG-27102021-07-02
D066PG33041PlastCarePG-3304PG-33042021-07-02
D066PG33121PlastCarePG-3312PG-33122021-07-02
D066PG35101PlastCarePG-3510PG-35102021-07-02
D066PG35651PlastCarePG-3565PG-35652021-07-02
D066PG43121PlastCarePG-4312PG-43122021-07-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456202418JMUJMU DENTAL, INCEIC2026-07-27
00840456214527JMUJMU DENTAL, INCEIC2026-07-27
00840456214534JMUJMU DENTAL, INCEIC2026-07-27
00840456214541JMUJMU DENTAL, INCEIC2026-07-27
00840456214558JMUJMU DENTAL, INCEIC2026-07-27
00840456214565JMUJMU DENTAL, INCEIC2026-07-27
00840456214572JMUJMU DENTAL, INCEIC2026-07-27
00840456214589JMUJMU DENTAL, INCEIC2026-07-27
00840456214596JMUJMU DENTAL, INCEIC2026-07-27
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
00850440008650Capillary Tip - PremiumEngineered Endodontics, LLCEIC2026-01-02