FDA.report

Plasdent

Primary DI
D832PFHC20
Brand
Plasdent
Company
PLASDENT CORPORATION
Model
PFHC-2
Catalog number
PFHC-2
Device description
Patient Face & Chest Cover, Blue, 18"W X 21"L, 2-Ply+Poly, Disposable
Published
2022-03-25
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

Related Records

Product Codes

CodeName
NRDUnit, Operative Dental, Accessories

Product Code Classifications

CodeDeviceSpecialtyClass
NRDUnit, Operative Dental, AccessoriesDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D832PFHC21PrimaryHIBCC0
D832PFHC20Unit of UseHIBCC0

GMDN Terms

TermDefinition
Dental bibA non-sterile device intended to be worn by a patient during a dental examination or treatment procedure to function as a barrier to soiling and cross-contamination. It typically consists of a shaped piece of natural and/or synthetic material intended to be fastened around the neck and cover the front side of the upper body. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
190377184
Device count
200
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

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D8323000B0EXPANDII FLOSSII3000B3000B2025-06-02
D8323000T0EXPANDII FLOSSII3000T3000T2025-06-02
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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

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