MAXAPPLICATOR II 600B-F-400

GUDID D832600BF4000

Applicators - Fine, Assorted 2 colors

PLASDENT CORPORATION

Dental material application tool, single-use
Primary Device IDD832600BF4000
NIH Device Record Keyc5c99a9d-257c-4653-9dd8-eb6a50f64c24
Commercial Distribution StatusIn Commercial Distribution
Brand NameMAXAPPLICATOR II
Version Model Number600B-F-400
Catalog Number600B-F-400
Company DUNS190377184
Company NamePLASDENT CORPORATION
Device Count400
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD832600BF4000 [Unit of Use]
HIBCCD832600BF4001 [Primary]

FDA Product Code

KXFApplicator, Absorbent Tipped, Non-Sterile

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-08-11
Device Publish Date2025-08-01

On-Brand Devices [MAXAPPLICATOR II]

D832600BSF4000Applicators - Super Fine, White
D832600BR4000Applicators - Regular, Assorted 4 colors
D832600BF4000Applicators - Fine, Assorted 2 colors
D832600BA4000Applicators - Assorted Sizes, Assorted 4 colors

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