FDA.report

Plasdent

Primary DI
D832IPM2FD0
Brand
Plasdent
Company
PLASDENT CORPORATION
Model
IPM-2FD
Catalog number
IPM-2FD
Device description
Photography Mirror, XL Child Occlusal
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
false

Related Records

Product Codes

CodeName
EAXMirror, Mouth

Product Code Classifications

CodeDeviceSpecialtyClass
EAXMirror, MouthDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D832IPM2FD0PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental mirror, reusableA hand-held, dental instrument intended to be used by a dentist for intraoral inspection or inspection and retraction. It typically consists of a stainless steel shaft terminating at the distal end in a small round mirror that is angled to the shaft. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
190377184
Device count
1
DM exempt
true
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 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 DIBrandCompanyProduct codePublished
04251436934155KOHLERKohler Medizintechnik GmbHEAX2026-03-12
00840161311511Crystal HD® Mouth MirrorsZIRC DENTAL PRODUCTS, INC.EAX2026-02-19
00840161311535Crystal HD® Mouth MirrorsZIRC DENTAL PRODUCTS, INC.EAX2026-02-19
00840161311375Crystal HD® Mouth MirrorsZIRC DENTAL PRODUCTS, INC.EAX2026-01-05
00840161311382Crystal HD® Mouth MirrorsZIRC DENTAL PRODUCTS, INC.EAX2026-01-05
00840161311399Crystal HD® Mouth MirrorsZIRC DENTAL PRODUCTS, INC.EAX2026-01-05
00840161311405Crystal HD® Mouth MirrorsZIRC DENTAL PRODUCTS, INC.EAX2026-01-05
00840161311412Crystal HD® Mouth MirrorsZIRC DENTAL PRODUCTS, INC.EAX2026-01-05
00840161311429Crystal HD® Mouth MirrorsZIRC DENTAL PRODUCTS, INC.EAX2026-01-05
00840161311436Crystal HD® Mouth MirrorsZIRC DENTAL PRODUCTS, INC.EAX2026-01-05
00840161311443Crystal HD® Mouth MirrorsZIRC DENTAL PRODUCTS, INC.EAX2026-01-05
00810126506726Essentials By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEAX2025-12-16
008101265067713D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEAX2025-12-16
00190707193225PixSure Perfect™Ortho Organizers, Inc.EAX2025-10-23
00190707193232PixSure Perfect™Ortho Organizers, Inc.EAX2025-10-23
00190707193249PixSure Perfect™Ortho Organizers, Inc.EAX2025-10-23
00190707193256PixSure Perfect™Ortho Organizers, Inc.EAX2025-10-23
00190707193263PixSure Perfect™Ortho Organizers, Inc.EAX2025-10-23
00190707193270PixSure Perfect™Ortho Organizers, Inc.EAX2025-10-23
00190707149055PixSure Perfect®Ortho Organizers, Inc.EAX2025-10-01
0081000052669720/20™PARKELL, INC.EAX2025-09-26
D909800050M1ORTHO ARCHOrtho Arch Company IncEAX2025-09-15
D9098010201ORTHO ARCHOrtho Arch Company IncEAX2025-08-27
D9098010211ORTHO ARCHOrtho Arch Company IncEAX2025-08-27
D90980102210ORTHO ARCHOrtho Arch Company IncEAX2025-08-27
D90980102311ORTHO ARCHOrtho Arch Company IncEAX2025-08-27
D90980102412ORTHO ARCHOrtho Arch Company IncEAX2025-08-27
D90980102513ORTHO ARCHOrtho Arch Company IncEAX2025-08-27
D90980102614ORTHO ARCHOrtho Arch Company IncEAX2025-08-27
D9098010301ORTHO ARCHOrtho Arch Company IncEAX2025-08-27