FDA.reportPublic FDA data

Premier SENSIPAST

Primary DI
D6919053571
Brand
Premier SENSIPAST
Company
PREMIER DENTAL PRODUCTS COMPANY
Model
9053571
Device description
FILLER SENSIPAST PKG4 21MM 25
Published
2023-10-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EIYInstrument, Filling, Plastic, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIYInstrument, Filling, Plastic, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D6919053571PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Endodontic obturation material distribution endpiece, reusableA dental endpiece designed to be attached to a dental power tool handpiece to distribute root canal sealer/cement/paste evenly throughout the root canal system typically by applying the material in a lateral direction. It is a thin metal rod with a spiral (e.g., Lentulo spiral type), helicoidal, or circular design. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
014789663
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00348783008265Premier Cavity Prep10031892026-04-01
00348783008722Premier Applicators10031152026-04-01
00348783008975Premier Pluggers10038162026-04-29
00348783008982Premier Pluggers10038172026-04-29
00348783009125Premier Pluggers10038022026-04-29
00348783009507Premier Spreader10039052026-05-06
00348783009514Premier Spreader10039062026-05-06
00348783010176Premier Crown Removers10035762026-04-02
00348783009064Premier Pluggers10038812026-03-17
00348783009361Premier Burnisher10030272026-03-17
D6919053036Premier REAMERS90530362023-10-17
00348783011234Premier Jarcho Cannula10308402026-06-10
00348783011340Premier Needle Adapter10324532026-06-10
00348783011357Premier Needle Adapter10324542026-06-10
00348783011364Premier Needle Adapter10324552026-06-10
00348783011371Premier Needle Adapter10324562026-06-10
00348783011456Premier Sawyer Retractor10501052026-06-10
00348783011463Premier Sawyer Retractor10501062026-06-10
00348783012415Premier Jackson Improved Short Tracheostomy Tube81000412026-06-10
00348783015591Bond-PR30052502026-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06954454001615COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454002681COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454002698COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454004227COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454004234COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454004241COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454004258COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454004265COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454004272COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454004289COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454004296COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454004302COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454004319COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454006382COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454006399COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454006405COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454012024COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454014523COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454014530COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454014547COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454015230COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454015360COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454015377COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454015384COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454015391COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454015407COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454015414COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454015421COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454015438COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454015445COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27