FDA.report

Plasdent

Primary DI
D83280800
Brand
Plasdent
Company
PLASDENT CORPORATION
Model
8080
Catalog number
8080
Device description
Clear Impression Syringes, Disposable, Bendable Tip
Published
2022-01-14
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
EIDSyringe, Restorative And Impression Material

Product Code Classifications

CodeDeviceSpecialtyClass
EIDSyringe, Restorative And Impression MaterialDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D83280801PrimaryHIBCC0
D83280800Unit of UseHIBCC0

GMDN Terms

TermDefinition
Dental impression material syringe, reusableA non-sterile hand-held manual dental instrument designed to inject impression material into an impression tray or directly into a patient's mouth. This is a reusable device.

Sterilization Methods

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

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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

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00304040194799Henry ScheinHENRY SCHEIN, INC.EID2026-01-20
00304040194805Henry ScheinHENRY SCHEIN, INC.EID2026-01-20
00371347019889Advance Dental ProductsThe Atlanta Dental Supply CompanyEID2025-12-30
00841336104877Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEID2025-12-22
00841336104891Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEID2025-12-22
00841336104907Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEID2025-12-22
00841336104914Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEID2025-12-22
00810126504357Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEID2025-12-16
00810126504388Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEID2025-12-16
00371347017786Advance Dental ProductsThe Atlanta Dental Supply CompanyEID2025-11-18
08800017902265DX-MixerDXM CO., LTDEID2025-09-29
20840326424302DefendYoung Innovations, Inc.EID2025-09-05
00883205032041ExperTempULTRADENT PRODUCTS, INC.EID2025-08-23
E217172261Mixing TipsKettenbach GmbH & Co. KGEID2025-08-14
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00195062154119Kerr RestorativesKerr CorporationEID2025-08-08
00195062154126Kerr RestorativesKerr CorporationEID2025-08-08
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00195062154157Kerr RestorativesKerr CorporationEID2025-08-08
00195062154164Kerr RestorativesKerr CorporationEID2025-08-08
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E239D49701X61Mixing tipsDreve Dentamid GmbHEID2025-07-18
00359883007201EVANESCEDEN-MAT HOLDINGS, LLCEID2025-05-30
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E217150221Application TipsKettenbach GmbH & Co. KGEID2025-04-03
E217150231Application TipsKettenbach GmbH & Co. KGEID2025-04-03