FDA.reportPublic FDA data

Plasdent

Primary DI
D832MG0040
Brand
Plasdent
Company
PLASDENT CORPORATION
Model
MG004
Catalog number
MG004
Device description
Teeth Bleaching Trays, One Size, Boil & Bite Moldable
Published
2022-01-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
BRWProtector, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BRWProtector, DentalAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D832MG0041PrimaryHIBCC0
D832MG0040Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Teeth whitening trayA custom-made device intended to retain a bleaching agent for whitening natural teeth through bleaching. It is made of polymer materials in the form of a mould to fit precisely over the teeth for a specified patient. This is a single-patient reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
190377184
Device count
12
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
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
D832BLT4251PlasdentBLT-425BLT-4252026-05-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250676748188Endoragard teeth protectorSpiggle & Theis Medizintechnik GmbHBRW2026-04-27
08800017902289EZ BITE BLOCK SOFT MOUTH PROP DXM CO., LTDBRW2025-12-18
08800017902296EZ BITE BLOCK SOFT MOUTH PROP DXM CO., LTDBRW2025-12-18
08800017902302EZ BITE BLOCK SOFT MOUTH PROP DXM CO., LTDBRW2025-12-18
08800017902319EZ BITE BLOCK SOFT MOUTH PROP DXM CO., LTDBRW2025-12-18
08800017901817EZ Bite blockDXM CO., LTDBRW2025-12-16
08800017900605EZ Bite blockDXM CO., LTDBRW2025-12-16
00194613123468MSI Precision Specialty InstrumentsMed Saver, Inc.BRW2025-08-01
08800142100949Tera Harz GuardGraphy Inc.BRW2025-07-18
00885797099365RMORmo, Inc.BRW2024-09-02
00885797099372RMORmo, Inc.BRW2024-09-02
00885797099396RMORmo, Inc.BRW2024-09-02
00885797099402RMORmo, Inc.BRW2024-09-02
00885797672278RMORmo, Inc.BRW2024-08-26
00885797672292RMORmo, Inc.BRW2024-08-26
00000008857972RMORmo, Inc.BRW2024-08-12
10889483007563SunMedSUNMED, LLCBRW2024-03-12
08800075604170OSUNG MNDOSUNG MND Co., Ltd.BRW2024-02-19
08800075604187OSUNG MNDOSUNG MND Co., Ltd.BRW2024-02-19
08800075604194OSUNG MNDOSUNG MND Co., Ltd.BRW2024-02-19
00630094199702Bioseal Inc.BIOSEALBRW2023-12-12
10630094199709Bioseal Inc.BIOSEALBRW2023-12-12
00630094199207Bioseal Inc.BIOSEALBRW2023-12-11
00630094199252Bioseal Inc.BIOSEALBRW2023-12-11
00630094199306Bioseal Inc.BIOSEALBRW2023-12-11
00630094199320Bioseal Inc.BIOSEALBRW2023-12-11
10630094199204Bioseal Inc.BIOSEALBRW2023-12-11
10630094199259Bioseal Inc.BIOSEALBRW2023-12-11
10630094199303Bioseal Inc.BIOSEALBRW2023-12-11
10630094199327Bioseal Inc.BIOSEALBRW2023-12-11