FDA.reportPublic FDA data

Plasdent

Primary DI
D832MURM1
Brand
Plasdent
Company
PLASDENT CORPORATION
Model
MUR-M
Catalog number
MUR-M
Device description
Mouth Retractor Ring, Regular
Published
2025-06-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
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
D832MURM1PrimaryHIBCC0
D832MURM0Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental cheek retractor, professional, single-useA 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 single-use device.

Regulatory Flags#

DUNS number
190377184
Device count
20
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D832SPD05081PlasdentSPD-0508SPD-05082026-07-20
D832MTXA15021PlasdentMTXA-1502MTXA-15022026-06-04
D832MTXA15031PlasdentMTXA-1503MTXA-15032026-06-04
D832BLT100501PlasdentBLT-100-50BLT-100-502026-05-28
D832BEE0001PlasdentBEE-000BEE-0002026-05-06
D832BEE0011PlasdentBEE-001BEE-0012026-05-06
D832BEE0021PlasdentBEE-002BEE-0022026-05-06
D832906CDG20Plasdent906CDG2906CDG22026-05-01
D832906CDG30Plasdent906CDG3906CDG32026-05-01
D832BLT1011PlasdentBLT-101BLT-1012026-05-01
D832BLT2001PlasdentBLT-200BLT-2002026-05-01
D832BLT2011PlasdentBLT-201BLT-2012026-05-01
D832BLT3001PlasdentBLT-300BLT-3002026-05-01
D832BLT3011PlasdentBLT-301BLT-3012026-05-01
D832BLT3021PlasdentBLT-302BLT-3022026-05-01
D832BLT4181PlasdentBLT-418BLT-4182026-05-01
D832BLT4201PlasdentBLT-420BLT-4202026-05-01
D832BLT4211PlasdentBLT-421BLT-4212026-05-01
D832BLT4221PlasdentBLT-422BLT-4222026-05-01
D832BLT4231PlasdentBLT-423BLT-4232026-05-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00883205029102OpalDamULTRADENT PRODUCTS, INC.EIG2026-08-22
00883205029119OpalDamULTRADENT PRODUCTS, INC.EIG2026-08-22
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
G8791030240DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G879103024L0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G8791030250DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G8791030260DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G8791030380DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G8791031820DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G8791031830DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G879103185L0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G879103185M0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G879103185S0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G8791048560DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G8791062470DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G8791062480DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G879KLB25060DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G879KLB36110DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
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