FDA.reportPublic FDA data

Parkell®

Primary DI
00810000528257
Brand
Parkell®
Company
PARKELL, INC.
Model
S391
Catalog number
S391
Device description
Fine (1.5mm) Micro Brush Applicator Refill (100)
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
10810000528254PrimaryGS10
00810000528257Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081000052825410810000528254
00810000528257008100005282578100005282570810000528257

GMDN Terms#

Term, Definition table
TermDefinition
Dental material application tool, single-useA hand-held manual dental instrument intended to be used for the application of a dental restorative material (e.g., amalgam, resin) to a patient’s tooth/teeth; the restorative material is not included. It includes a handle with an application tip/brush which holds the material on its surface/bristles; it is not a syringe- or pistol-like device. 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
100
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
00810000525782HyperFIL®S235SPS235SP2025-09-26
00810000528271TriPhasix™S408S4082025-09-26
0081000052669720/20™S575S5752025-09-26
00810000522934DuraTip®DURA30-PSLDURA30-PSL2025-07-18
00810000522941DuraTip®DURA30-PSRDURA30-PSR2025-07-18
00810000525751HyperFIL®S236S2362025-03-28
00810000525768HyperFIL®S237S2372025-03-28
00810000525775HyperFIL®S238S2382025-03-28
10810000520319Integra™D681D6812018-11-16
00810000521579PureClarity™D719D7192024-12-13
00810000521647PureClarity™D718D7182024-12-13
00810000525744OTCS833S8332024-06-28
10810000525086Dryz™S180S1802018-09-21
00810000525720HyperFIL®S234S2342024-03-01
00810000525737HyperFIL®S235S2352024-03-01
1081000052758520/20™S475S4752019-08-30
10810000524409Cinch™S469S4692019-07-26
10810000524416Cinch™S470S4702019-07-26
10810000524133Mach-2®S433S433S2018-10-19
10810000524157Blu-Mousse®S437SS437S2018-10-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850440008582ActaCal Calcium Hydroxide PasteEngineered Endodontics, LLCEJK2026-01-02
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
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
D967300010ApaCal ARTPREVEST DENPRO LIMITEDEJK2022-12-06
D96730001A04ApaCal ARTPREVEST DENPRO LIMITEDEJK2022-12-06
00887919880226Brasseler USAPeter Brasseler Holdings, LLCEJK2022-12-01
00810111540018TheraCal LCBISCO INC.EJK2022-11-17
00766054002901Bio-LCBESSENTIAL DENTAL SYSTEMS, INC.EJK2022-10-28
00766054002918Bio-LCBESSENTIAL DENTAL SYSTEMS, INC.EJK2022-10-28
00766054002932Bio-LCBESSENTIAL DENTAL SYSTEMS, INC.EJK2022-10-28