Acorn Nano Micro Hybrid-Syringe Shade B1 0018

GUDID D83600180

Acorn composite suitable for: Class III, IV, V, as well as, class I and II restorations. Fabrication of extra orally tempered inlays-and onlays by the direct or indirect method, as well as, fabrication of extraorally tempered custom made veneers. A highly polishable, photocuring, Nano-Micro Hybrid composite for anterior and posterior restorations.

DENT ZAR, INC.

Dental composite resin
Primary Device IDD83600180
NIH Device Record Key9161487b-e418-4e49-9e7b-3ed3bca7ea7e
Commercial Distribution StatusIn Commercial Distribution
Brand NameAcorn Nano Micro Hybrid-Syringe Shade B1
Version Model Number0018
Catalog Number0018
Company DUNS789664455
Company NameDENT ZAR, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD83600180 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBFMaterial, Tooth Shade, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-02

Devices Manufactured by DENT ZAR, INC.

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D83600080 - Acorn Nano Micro Hybrid-Syringe Shade A12018-07-06 Acorn composite suitable for: Class III, IV, V, as well as, class I and II restorations. Fabrication of extra orally tempered in
D83600090 - Acorn Nano Micro Hybrid-Syringe Shade A22018-07-06 Acorn composite suitable for: Class III, IV, V, as well as, class I and II restorations. Fabrication of extra orally tempered in
D83600100 - Acorn Nano Micro Hybrid-Syringe Shade A32018-07-06 Acorn composite suitable for: Class III, IV, V, as well as, class I and II restorations. Fabrication of extra orally tempered in
D83600110 - Acorn Nano Micro Hybrid-Syringe Shade B22018-07-06 Acorn composite suitable for: Class III, IV, V, as well as, class I and II restorations. Fabrication of extra orally tempered in
D83600120 - Acorn Nano Micro Hybrid-Syringe Shade A42018-07-06 Acorn composite suitable for: Class III, IV, V, as well as, class I and II restorations. Fabrication of extra orally tempered in

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