Dispensing Straws

GUDID D701APS1002

Package of 100

PULPDENT CORPORATION

Dental material application tool, single-use Dental material application tool, single-use Dental material application tool, single-use Dental material application tool, single-use Dental material application tool, single-use Dental material application tool, single-use Dental material application tool, single-use Dental material application tool, single-use Dental material application tool, single-use Dental material application tool, single-use Dental material application tool, single-use Dental material application tool, single-use Dental material application tool, single-use Dental material application tool, single-use Dental material application tool, single-use Dental material application tool, single-use Dental material application tool, single-use
Primary Device IDD701APS1002
NIH Device Record Key78f5a2d6-f6d3-4b13-965e-a39cea6c98b4
Commercial Distribution StatusIn Commercial Distribution
Brand NameDispensing Straws
Version Model NumberAPS100
Company DUNS001006089
Company NamePULPDENT CORPORATION
Device Count100
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
HIBCCD701APS1001 [Unit of Use]
HIBCCD701APS1002 [Primary]

FDA Product Code

KXRApplicator, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-01
Device Publish Date2021-09-23

Devices Manufactured by PULPDENT CORPORATION

D701SUNO2 - DENTASTIC UNO SAMPLE2024-02-16 Adhesive, dentine, applicator brush
D701SVPFA32 - Activa Presto2023-06-30 .6 mL sample A3 shade + 5 tips
D701SVPFA352 - Activa Presto2023-06-30 .6 mL sample A3.5 shade + 5 tips
D701SVPFA42 - Activa Presto2023-06-30 .6 mL sample A4 shade + 5 tips
D701SVPFA62 - Activa Presto2023-06-30 .6 mL sample A6 shade + 5 tips
D701SVPFB12 - Activa Presto2023-06-30 .6 mL sample B1 shade + 5 tips
D701TTP502 - Tuff Temp Plus Provisional Veneer, Crown, and Bridge Resin2021-10-29 50 mL automix syringe cartridge with ten applicator tips
D701TTP50A12 - TUFF-TEMP PLUS2021-10-29 TUFF-TEMP PLUS A1 SHADE 50 ml cartridge + 10 tips only

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