Acrylic Block TS03US

GUDID 14560227799201

Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture base using a CAD/CAM system. The size of the product is

SUN MEDICAL CO.,LTD.

Dental appliance fabrication material, thermoplastic
Primary Device ID14560227799201
NIH Device Record Keyeb354040-e33e-4cad-b281-571a597217e2
Commercial Distribution Discontinuation2018-05-01
Commercial Distribution StatusNot in Commercial Distribution
Brand NameAcrylic Block
Version Model NumberMCL-011-A
Catalog NumberTS03US
Company DUNS690922612
Company NameSUN MEDICAL CO.,LTD.
Device Count5
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Dimensions

Depth35 Millimeter
Width109 Millimeter
Length109 Millimeter
Depth35 Millimeter
Width109 Millimeter
Length109 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104560227799010 [Unit of Use]
GS114560227799201 [Primary]
GS124560227799324 [Package]
Package: Cardboard [4 Units]
Discontinued: 2018-05-01
Not in Commercial Distribution

FDA Product Code

EBIResin, Denture, Relining, Repairing, Rebasing

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-05-24
Device Publish Date2016-11-07

On-Brand Devices [Acrylic Block]

14560227799300Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture ba
14560227799294Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture ba
14560227799287Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture ba
14560227799270Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture ba
14560227799263Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture ba
14560227799256Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture ba
14560227799249Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture ba
14560227799232Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture ba
14560227799225Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture ba
14560227799218Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture ba
14560227799201Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture ba
14560227799195Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture ba

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