FDA.reportPublic FDA data

Premier Retraction Cap

Primary DI
00348783003611
Brand
Premier Retraction Cap
Company
PREMIER DENTAL PRODUCTS COMPANY
Model
9048699
Device description
SAMPLE – Retraction Caps – 3 - #5, 1 - #3, 1 - #1
Published
2022-06-29
Public version status
Update
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
NYFGingival Retraction Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NYFGingival Retraction KitDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00348783003611PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00348783003611003487830036113487830036110348783003611

GMDN Terms#

Term, Definition table
TermDefinition
Gingival retraction cord, non-medicatedA non-medicated cotton string intended to be used to temporarily push gum tissue (gingiva) away from prepared tooth margins to help make an accurate dental impression. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
014789663
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00348783010749Premier Jackson Original Tracheostomy Tube10343192026-06-09
00348783010756Premier Jackson Original Tracheostomy Tube10343202026-06-09
00348783010770Premier Jackson Improved Tracheostomy Tube10346102026-06-09
00348783010787Premier Jackson Improved Tracheostomy Tube10346112026-06-09
00348783010794Premier Jackson Improved Tracheostomy Tube10346122026-06-09
00348783010800Premier Jackson Improved Tracheostomy Tube10346132026-06-09
00348783010817Premier Jackson Improved Tracheostomy Tube10346142026-06-09
00348783010824Premier Jackson Improved Tracheostomy Tube10346152026-06-09
00348783010831Premier Jackson Improved Tracheostomy Tube10346162026-06-09
00348783010848Premier Jackson Improved Tracheostomy Tube10346172026-06-09
00348783010855Premier Jackson Improved Tracheostomy Tube10346182026-06-09

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
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
D6919048260PremierPREMIER DENTAL PRODUCTS COMPANYNYF2022-06-29
D6919048699PremierPREMIER DENTAL PRODUCTS COMPANYNYF2022-06-29