FDA.reportPublic FDA data

Plasdent

Primary DI
D832820210N0
Brand
Plasdent
Company
PLASDENT CORPORATION
Model
8202-10N
Catalog number
8202-10N
Device description
Micro Applicators - Purple
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

Product Codes#

Code, Name table
CodeName
KXFApplicator, Absorbent Tipped, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXFApplicator, Absorbent Tipped, Non-SterileGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D832820210N1PrimaryHIBCC0
D832820210N0Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental material application tool, single-useA hand-held manual dental instrument intended to be used for the application of a dental restorative material (e.g., amalgam, resin) to a patient’s tooth/teeth; the restorative material is not included. It includes a handle with an application tip/brush which holds the material on its surface/bristles; it is not a syringe- or pistol-like device. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
190377184
Device count
144
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
57613327680756Q-CareSAGE PRODUCTS, LLCKXF2025-12-03
30889483563278BALLARD™SUNMED, LLCKXF2025-11-17
30889483563292BALLARD™SUNMED, LLCKXF2025-11-17
10889483563304BALLARD™SUNMED, LLCKXF2025-11-17
30889483563322BALLARD™SUNMED, LLCKXF2025-11-17
30889483563346BALLARD™SUNMED, LLCKXF2025-11-17
30889483565524BALLARD™SUNMED, LLCKXF2025-11-17
30889483565531BALLARD™SUNMED, LLCKXF2025-11-17
30889483565548BALLARD™SUNMED, LLCKXF2025-11-17
M220761003Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.KXF2025-09-11
D832600BA4000MAXAPPLICATOR IIPLASDENT CORPORATIONKXF2025-08-01
D832600BF4000MAXAPPLICATOR IIPLASDENT CORPORATIONKXF2025-08-01
D832600BR4000MAXAPPLICATOR IIPLASDENT CORPORATIONKXF2025-08-01
D832600BSF4000MAXAPPLICATOR IIPLASDENT CORPORATIONKXF2025-08-01
00840456214893JMUJMU DENTAL, INCKXF2025-07-15
00840456214909JMUJMU DENTAL, INCKXF2025-07-15
00840456214930JMUJMU DENTAL, INCKXF2025-07-15
00840456209127JMUJMU DENTAL, INCKXF2025-06-17
00840456209134JMUJMU DENTAL, INCKXF2025-06-17
00840456209141JMUJMU DENTAL, INCKXF2025-06-17
00840456213742JMUJMU DENTAL, INCKXF2025-06-17
00840456213759JMUJMU DENTAL, INCKXF2025-06-17
00840456213766JMUJMU DENTAL, INCKXF2025-06-17
00840456213773JMUJMU DENTAL, INCKXF2025-06-17
00840456213780JMUJMU DENTAL, INCKXF2025-06-17
00840456213797JMUJMU DENTAL, INCKXF2025-06-17
00848253004037StomaSoft Cleaning SwabsFreudenberg Medical, LLCKXF2025-03-17
00854498007047SmartPracticeSmarthealth, Inc.KXF2025-02-17
30840330701458ProCureTwin Med, LLCKXF2024-11-14
30840330701465ProCureTwin Med, LLCKXF2024-11-14