FDA.reportPublic FDA data

Parkell®

Primary DI
00810000526833
Brand
Parkell®
Company
PARKELL, INC.
Model
S390
Catalog number
S390
Device description
Yellow PreBent Needle Tip Refill
Published
2021-06-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EJKLiner, Cavity, Calcium Hydroxide

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJKLiner, Cavity, Calcium HydroxideDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810000526830PrimaryGS10
00810000526833Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081000052683010810000526830
00810000526833008100005268338100005268330810000526833

GMDN Terms#

Term, Definition table
TermDefinition
Dental material injection cannula, single-useA rigid or semi-rigid luminal device (dental tip) intended to channel and dispense a dental material/solution [e.g., restorative amalgam, resin, etching solution (etchant), topical dental anaesthetic] from a dental syringe, or similar applicator, to a patient’s teeth, oral mucosa, or gums; it is not intended to penetrate tissue (it is not a needle), not dedicated to root canal irrigation, and may be used for dental applications outside the patients mouth. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
6312491134customerservice@parkell.com

Regulatory Flags#

DUNS number
009900424
Device count
30
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
false
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M595S367UD1Epic®S367UDS367UD2016-09-23
M595S4130NAS413S4132016-09-23
00810000529568TotalBond®S413S4132018-11-23
00810000522729GentleCLEAN™DSG30GCPDSG30GCP2018-11-02
10810000527554Parkell®S276S2762018-10-19
M595S3930NAS393S3932016-09-23
M595S3940NAS394S3942016-09-23
M595S3950C&B METABOND®S395S3952016-09-23
00810000529070C&B METABOND®S394S3942018-11-23
00810000529193C&B METABOND®S393S3932018-11-23
00810000529209C&B METABOND®S395S3952018-11-23
00810000525294SmarTemp®S338S3382018-10-26
1081000052669420/20™S575S5752025-09-26
00810000525782HyperFIL®S235SPS235SP2025-09-26
00810000528271TriPhasix™S408S4082025-09-26
0081000052669720/20™S575S5752025-09-26
M595D6750Aurora™D675D6752016-09-24
00810000520053Parkell®D675D6752018-11-16
00810000522934DuraTip®DURA30-PSLDURA30-PSL2025-07-18
00810000522941DuraTip®DURA30-PSRDURA30-PSR2025-07-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00197998302732Solventum™ Vitrebond™Solventum US LLCEJK2025-09-29
D161250010AxioPro ARTAxiodent Inc.EJK2024-10-04
D161250020AxioPro ARTAxiodent Inc.EJK2024-10-04
D161250040AxioCAL LCAxiodent Inc.EJK2024-10-04
D161250050AxioCAL LCAxiodent Inc.EJK2024-10-04
D161250060AxioCAL LCAxiodent Inc.EJK2024-10-04
D161250080AxioCAL Axiodent Inc.EJK2024-10-04
D161250090AxioCAL Axiodent Inc.EJK2024-10-04
D161250100AxioCAL Axiodent Inc.EJK2024-10-04
D161250110AxioCAL Axiodent Inc.EJK2024-10-04
D161250150AxioCAL SC Axiodent Inc.EJK2024-10-04
D161250160AxioCAL SC Axiodent Inc.EJK2024-10-04
D161250170AxioCAL LC Axiodent Inc.EJK2024-10-04
D161250180AxioPro ARTAxiodent Inc.EJK2024-10-04
00810111542937TheraCal PTBISCO INC.EJK2024-04-03
00810111542944TheraCal PTBISCO INC.EJK2024-04-03
00810118103995NuSmile NeoLINER LC Sample Pack (1 g Syringe + 5 Tips, No IFU)NUSMILE, LTD.EJK2023-11-30
08800071200017CleaniCalMARUCHIEJK2023-05-16
106058610830553M™3M COMPANYEJK2023-04-28
D95600APEXH0ApexPaste HardD.S.I DENTAL SOLUTIONS LTDEJK2023-02-15
D956APEXBIO0ApexPaste BioD.S.I DENTAL SOLUTIONS LTDEJK2023-02-15
D956APEXC2G0ApexPaste D.S.I DENTAL SOLUTIONS LTDEJK2023-02-15
D956CALPSLC0CalPaste LCD.S.I DENTAL SOLUTIONS LTDEJK2023-02-15
D9673000110ApaCal ARTPREVEST DENPRO LIMITEDEJK2023-01-03
D9673000510Cal LCPREVEST DENPRO LIMITEDEJK2023-01-03
D967400070CalcigelPREVEST DENPRO LIMITEDEJK2023-01-03
D9674000710CalcigelPREVEST DENPRO LIMITEDEJK2023-01-03
D9674000720CalcigelPREVEST DENPRO LIMITEDEJK2023-01-03
D967400080CalcigelPREVEST DENPRO LIMITEDEJK2023-01-03