FDA.reportPublic FDA data

Premier

Primary DI
D6919048251
Brand
Premier
Company
PREMIER DENTAL PRODUCTS COMPANY
Model
9048251
Device description
Premier Retraction Cap Size 1- (Qty 120)
Published
2022-06-29
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

Product Codes#

Code, Name table
CodeName
NYFGingival Retraction Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NYFGingival Retraction KitDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D6919048251PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Gingival retraction cord, non-medicatedA non-medicated, cotton string used to temporarily hold off the gingiva during abutment preparation. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
014789663
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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
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
00348783015607Bond-PR30052552026-06-10
00348783015614Bond-PR30052692026-06-10
00348783010640Premier Jackson Original Tracheostomy Tube10343002026-06-09
00348783010657Premier Jackson Original Tracheostomy Tube10343102026-06-09
00348783010664Premier Jackson Original Tracheostomy Tube10343112026-06-09
00348783010671Premier Jackson Original Tracheostomy Tube10343122026-06-09
00348783010695Premier Jackson Original Tracheostomy Tube10343142026-06-09
00348783010701Premier Jackson Original Tracheostomy Tube10343152026-06-09
00348783010718Premier Jackson Original Tracheostomy Tube10343162026-06-09
00348783010725Premier Jackson Original Tracheostomy Tube10343172026-06-09
00348783010732Premier Jackson Original Tracheostomy Tube10343182026-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00348783001068HemodentPREMIER DENTAL PRODUCTS COMPANYNYF2023-06-13
00348783001082HemodentPREMIER DENTAL PRODUCTS COMPANYNYF2023-06-13
00348783001105HemodentPREMIER DENTAL PRODUCTS COMPANYNYF2023-06-13
00348783003611Premier Retraction CapPREMIER DENTAL PRODUCTS COMPANYNYF2022-06-29
00348783003628Premier Retraction CapPREMIER DENTAL PRODUCTS COMPANYNYF2022-06-29
00348783003635Premier Retraction CapPREMIER DENTAL PRODUCTS COMPANYNYF2022-06-29
00348783003642Premier Retraction CapPREMIER DENTAL PRODUCTS COMPANYNYF2022-06-29
00348783003659Premier Retraction CapPREMIER DENTAL PRODUCTS COMPANYNYF2022-06-29
00348783001860Knit-PakPREMIER DENTAL PRODUCTS COMPANYNYF2022-06-29
00348783001877Knit-PakPREMIER DENTAL PRODUCTS COMPANYNYF2022-06-29
00348783001884Knit-PakPREMIER DENTAL PRODUCTS COMPANYNYF2022-06-29
00348783001891Knit-PakPREMIER DENTAL PRODUCTS COMPANYNYF2022-06-29
00348783001907Knit-PakPREMIER DENTAL PRODUCTS COMPANYNYF2022-06-29
00348783001914Knit-PakPREMIER DENTAL PRODUCTS COMPANYNYF2022-06-29
00348783001921Knit-PakPREMIER DENTAL PRODUCTS COMPANYNYF2022-06-29
D6919007551Knit-PakPREMIER DENTAL PRODUCTS COMPANYNYF2022-06-29
D6919007552Knit-PakPREMIER DENTAL PRODUCTS COMPANYNYF2022-06-29
D6919007553Knit-PakPREMIER DENTAL PRODUCTS COMPANYNYF2022-06-29
D6919007554Knit-PakPREMIER DENTAL PRODUCTS COMPANYNYF2022-06-29
D6919007555Knit-PakPREMIER DENTAL PRODUCTS COMPANYNYF2022-06-29
D6919007556Knit-PakPREMIER DENTAL PRODUCTS COMPANYNYF2022-06-29
D6919007559Knit-PakPREMIER DENTAL PRODUCTS COMPANYNYF2022-06-29
D6919048253PremierPREMIER DENTAL PRODUCTS COMPANYNYF2022-06-29
D6919048255PremierPREMIER DENTAL PRODUCTS COMPANYNYF2022-06-29
D6919048260PremierPREMIER DENTAL PRODUCTS COMPANYNYF2022-06-29
D6919048699PremierPREMIER DENTAL PRODUCTS COMPANYNYF2022-06-29