Artic 66080455

GUDID J014660804550

Artifical Teeth, resin

Heraeus Kulzer GmbH

Resin artificial teeth

• Primary Device ID: J014660804550
• NIH Device Record Key: 55b9318f-5f84-44d1-943c-77e4475ac13e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Artic
• Version Model Number: 66080455
• Catalog Number: 66080455
• Company DUNS: 315666321
• Company Name: Heraeus Kulzer GmbH
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J014660804550 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033628

FDA Product Code

• ELM: Denture, plastic, teeth

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-08
• Device Publish Date: 2022-05-31

On-Brand Devices [Artic]

• J014660807950: Artifical Teeth, resin
• J014660807940: Artifical Teeth, resin
• J014660807930: Artifical Teeth, resin
• J014660807920: Artifical Teeth, resin
• J014660807850: Artifical Teeth, resin
• J014660807840: Artifical Teeth, resin
• J014660807830: Artifical Teeth, resin
• J014660807820: Artifical Teeth, resin
• J014660807750: Artifical Teeth, resin
• J014660807740: Artifical Teeth, resin
• J014660807730: Artifical Teeth, resin
• J014660807720: Artifical Teeth, resin
• J014660807650: Artifical Teeth, resin
• J014660807640: Artifical Teeth, resin
• J014660807630: Artifical Teeth, resin
• J014660807620: Artifical Teeth, resin
• J014660807550: Artifical Teeth, resin
• J014660807540: Artifical Teeth, resin
• J014660807530: Artifical Teeth, resin
• J014660807520: Artifical Teeth, resin
• J014660807450: Artifical Teeth, resin
• J014660807440: Artifical Teeth, resin
• J014660807430: Artifical Teeth, resin
• J014660807420: Artifical Teeth, resin
• J014660807350: Artifical Teeth, resin
• J014660807340: Artifical Teeth, resin
• J014660807330: Artifical Teeth, resin
• J014660807320: Artifical Teeth, resin
• J014660807250: Artifical Teeth, resin
• J014660807240: Artifical Teeth, resin
• J014660807230: Artifical Teeth, resin
• J014660807220: Artifical Teeth, resin
• J014660807150: Artifical Teeth, resin
• J014660807140: Artifical Teeth, resin
• J014660807130: Artifical Teeth, resin
• J014660807120: Artifical Teeth, resin
• J014660807050: Artifical Teeth, resin
• J014660807040: Artifical Teeth, resin
• J014660807030: Artifical Teeth, resin
• J014660807020: Artifical Teeth, resin
• J014660806950: Artifical Teeth, resin
• J014660806940: Artifical Teeth, resin
• J014660806930: Artifical Teeth, resin
• J014660806920: Artifical Teeth, resin
• J014660806850: Artifical Teeth, resin
• J014660806840: Artifical Teeth, resin
• J014660806830: Artifical Teeth, resin
• J014660806820: Artifical Teeth, resin
• J014660806750: Artifical Teeth, resin
• J014660806740: Artifical Teeth, resin