FDA.reportPublic FDA data

Premier Retractors

Primary DI
00348783010220
Brand
Premier Retractors
Company
PREMIER DENTAL PRODUCTS COMPANY
Model
1003837
Device description
COLUMBIA CHEEK RETRACTOR
Published
2026-05-06
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
EIGRetractor, All Types

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIGRetractor, All TypesDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00348783010220PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00348783010220003487830102203487830102200348783010220

GMDN Terms#

Term, Definition table
TermDefinition
Dental cheek retractor, professional, reusableA hands-free, self-retaining frame intended to allow a dental professional to retract the lips/cheeks of a patient during an orthodontic or restorative dental procedure for easy access to the field of operation. It is designed to be placed in and around the lips/cheeks and may also be designed to displace the tongue. It is a synthetic polymer device which may include suction adaptors/tubing for saliva removal to maintain a dry field. It is not intended to be placed between the teeth (i.e., not a mouth gag). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
014789663
Device count
1
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

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Primary DI, Brand, Company table
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00883205029126OpalDamULTRADENT PRODUCTS, INC.EIG2026-08-22
00883205029133OpalDamULTRADENT PRODUCTS, INC.EIG2026-08-22
00883205029140OpalDamULTRADENT PRODUCTS, INC.EIG2026-08-22
00883205029157OpalDamULTRADENT PRODUCTS, INC.EIG2026-08-22
00190776426491MillenniumAvalign Technologies, Inc.EIG2026-08-18
00190776426514MillenniumAvalign Technologies, Inc.EIG2026-08-18
00190776426521MillenniumAvalign Technologies, Inc.EIG2026-08-18
00190776426538MillenniumAvalign Technologies, Inc.EIG2026-08-18
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G879103024L0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
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G8791030260DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
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G879103185M0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G879103185S0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
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G879KLB40110DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G879LB30100DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G879LB35140DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G879LB4013DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G879OBG30100DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15