FDA.reportPublic FDA data

Plasdent

Primary DI
D832MTX2650
Brand
Plasdent
Company
PLASDENT CORPORATION
Model
MTX2-65
Catalog number
MTX2-65
Device description
6.5mm Matrices w/ Holes
Published
2022-01-27
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
NRDUnit, Operative Dental, Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NRDUnit, Operative Dental, AccessoriesDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D832MTX2651PrimaryHIBCC0
D832MTX2650Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic metal bandA thin metal ring designed to be fitted around the contours of a tooth and cemented into place to support an orthodontic attachment (e.g., bracket, tube), brazed or soldered onto the ring, intended to be secured to the tooth. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
190377184
Device count
50
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
D832600BA4000MAXAPPLICATOR II600B-A-400600B-A-4002025-08-01
D832600BF4000MAXAPPLICATOR II600B-F-400600B-F-4002025-08-01
D832600BR4000MAXAPPLICATOR II600B-R-400600B-R-4002025-08-01
D832600BSF4000MAXAPPLICATOR II600B-SF-400600B-SF-4002025-08-01
D83230000EXPANDII FLOSSII300030002025-06-02
D8323000B0EXPANDII FLOSSII3000B3000B2025-06-02
D8323000T0EXPANDII FLOSSII3000T3000T2025-06-02
D83231000FINE FLOSSII310031002025-06-02
D8323100B0FINE FLOSSII3100B3100B2025-06-02
D8323100T0FINE FLOSSII3100T3100T2025-06-02
D832CTRS20000PlasdentCTR-S2000CTR-S20002024-11-12
D832CTRS5400PlasdentCTR-S540CTR-S5402024-11-12
D8329000HVEXT0Plasdent 9000HV-EXT9000HV-EXT2024-09-06
D8329000PLG0Plasdent 9000PLG9000PLG2024-09-06
D832CCIMP20PlasdentCC-IMP2CC-IMP22024-09-06
D832TSTSA0ACUTIPS TST-SATST-SA2024-08-27
D832IITBIENAIR0PlasdentIIT-BIENAIRIIT-BIENAIR2024-07-30
D832IITKAVOT0PlasdentIIT-KAVO-TIIT-KAVO-T2024-07-30
D832IITNSK0PlasdentIIT-NSKIIT-NSK2024-07-30
D832IITU10PlasdentITT-U1ITT-U12024-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D12517802Premium PlusPremium Plus (Dongguan) LimitedNRD2026-05-22
D12517812Premium PlusPremium Plus (Dongguan) LimitedNRD2026-05-22
D12517822Premium PlusPremium Plus (Dongguan) LimitedNRD2026-05-22
00810126506511Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCNRD2025-12-16
00810126506528Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCNRD2025-12-16
00810126506535Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCNRD2025-12-16
00810126506559Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCNRD2025-12-16
00810126506573Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCNRD2025-12-16
00817169023708Essentials By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCNRD2025-12-16
00371347017878Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-24
00371347017885Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-24
00371347017830Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-18
00371347017847Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-18
00371347017854Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-18
00371347017861Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-18
06971119541897Air compressor Guangdong JINME Medical Technology Co., Ltd.NRD2025-07-23
06971119541903Testing machineGuangdong JINME Medical Technology Co., Ltd.NRD2025-07-23
10194665007935ActeonA-DEC, INC.NRD2025-05-15
D1302HD40BaseVacR. E. Morrison Equipment IncNRD2025-05-14
D1303HD40BaseVacR. E. Morrison Equipment IncNRD2025-05-14
D1304HD40BaseVacR. E. Morrison Equipment IncNRD2025-05-14
D130BVM10BaseVacR. E. Morrison Equipment IncNRD2025-05-14
D130BVM20BaseVacR. E. Morrison Equipment IncNRD2025-05-14
D130HD40BaseVacR. E. Morrison Equipment IncNRD2025-05-14
D678AS50X1AirStarAIR TECHNIQUES, INC.NRD2025-04-25
D678AS70X0AirStarAIR TECHNIQUES, INC.NRD2025-04-25
00304040190371Henry ScheinHENRY SCHEIN, INC.NRD2025-03-21
00304040190388Henry ScheinHENRY SCHEIN, INC.NRD2025-03-21
00304040190395Henry ScheinHENRY SCHEIN, INC.NRD2025-03-21
00304040190401Henry ScheinHENRY SCHEIN, INC.NRD2025-03-21