FDA.reportPublic FDA data

Pic-N-Stic

Primary DI
D701PIC2
Brand
Pic-N-Stic
Company
PULPDENT CORPORATION
Model
PIC
Device description
A handle for small objects
Published
2021-09-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
EKJBurnisher, Operative

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKJBurnisher, OperativeDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K911281000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K911281000PULPDENT PIC N STICPulpdent Corp.1991-05-15EKJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D701PIC2PrimaryHIBCC0
D701PIC1Unit of UseHIBCC0

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

Regulatory Flags#

DUNS number
001006089
Device count
60
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D701DEN2DENTIN CONDITIONING GELDEN2016-07-21
D701EA2ETCH-ALL™ EA2016-09-01
D701EA52ETCH-ALL™ Dental Etching Gel EA52016-07-28
D701ER2ETCH ROYALE™ DENTAL ETCHING GELER2016-08-11
D701ER242ETCH ROYALE™ DENTAL ETCHING GEL ER242016-08-11
D701ER502ETCH ROYALE™ DENTAL ETCHING GELER502016-08-11
D701ER50R2Etch RoyaleER50R2016-09-01
D701ER62ETCH ROYALE™ DENTAL ETCHING GEL ER62016-08-11
D701ET122ETCH-RITE™ DENTAL ETCHING GEL ET122016-07-28
D701ET12G2ETCH-RITE™ DENTAL ETCHING GEL ET12G2016-07-28
D701ET182ETCHANTET182016-09-01
D701ET242ETCH-RITE™ DENTAL ETCHING GEL ET242016-08-11
D701ET502ETCH-RITE™ DENTAL ETCHING GEL ET502016-08-11
D701ET50R2ETCH-RITE™ DENTAL ETCHING GELET50R2016-08-11
D701ET62ETCH-RITE™ DENTAL ETCHING GELET62016-07-28
D701ETCH2ETCH-RITE™ DENTAL ETCHING GELETCH2016-07-28
D701ETTWIN2ETCH-RITE™ DENTAL ETCHING GEL ETTWIN2016-07-28
D701SER2ETCH ROYALE SAMPLESER2018-08-10
D701SETCH2ETCH RITE SAMPLESETCH2018-08-10
D701ET1442ETCH-RITE™ DENTAL ETCHING GEL ET1442016-08-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00348783009682Premier Composite InstrumentsPREMIER DENTAL PRODUCTS COMPANYEKJ2026-04-02
00348783009378Premier BurnisherPREMIER DENTAL PRODUCTS COMPANYEKJ2026-04-01
00348783009385Premier BurnisherPREMIER DENTAL PRODUCTS COMPANYEKJ2026-04-01
00348783009392Premier BurnisherPREMIER DENTAL PRODUCTS COMPANYEKJ2026-04-01
00348783009408Premier BurnisherPREMIER DENTAL PRODUCTS COMPANYEKJ2026-04-01
00348783012293Premier ApplicatorsPREMIER DENTAL PRODUCTS COMPANYEKJ2026-04-01
10889950147372Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950147389Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950147716Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950147747Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950147754Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950147761Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950147792Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950147884Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950147914Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950148065Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950148102Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
00813677024978PDT, Inc.PDT, INC.EKJ2024-06-27
07898506811656QuinelatoSchobell Industrial LtdaEKJ2022-12-08
07898506843459QuinelatoSchobell Industrial LtdaEKJ2022-12-08
10889950004569HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKJ2020-11-12
10889950004576HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKJ2020-11-12
10889950004583HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKJ2020-11-12
10889950004590HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKJ2020-11-12
10889950004606HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKJ2020-11-12
10889950004613HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKJ2020-11-12
10889950004620HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKJ2020-11-12
10889950004637HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKJ2020-11-12
10889950004644HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKJ2020-11-12
10889950004651HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKJ2020-11-12