FDA.reportPublic FDA data

Premier

Primary DI
D6919048260
Brand
Premier
Company
PREMIER DENTAL PRODUCTS COMPANY
Model
9048260
Device description
Assorted Retraction Caps 15 - #1- 15 - #3, 30 - #5
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
D6919048260PrimaryHIBCC0

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
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
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
D6919048251PremierPREMIER DENTAL PRODUCTS COMPANYNYF2022-06-29
D6919048253PremierPREMIER DENTAL PRODUCTS COMPANYNYF2022-06-29
D6919048255PremierPREMIER DENTAL PRODUCTS COMPANYNYF2022-06-29
D6919048699PremierPREMIER DENTAL PRODUCTS COMPANYNYF2022-06-29