Vintage ZR 9098

GUDID E23590980

VINTAGE ZR BODY W2B 15g

SHOFU DENTAL CORPORATION

Dental appliance fabrication material, ceramic

• Primary Device ID: E23590980
• NIH Device Record Key: e7a87cf0-3eff-4599-b6d5-b2e92ab0556a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vintage ZR
• Version Model Number: 9098
• Catalog Number: 9098
• Company DUNS: 054618202
• Company Name: SHOFU DENTAL CORPORATION
• Device Count: 1
• DM Exempt: false
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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: 760-566-3528
• Email: ckaemmerlen@shofu.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E23590980 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052033

FDA Product Code

• EIH: Powder, Porcelain

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-24
• Device Publish Date: 2016-09-24

On-Brand Devices [Vintage ZR]

• E23592410: VINTAGE ZR HT UNI-LAYER 50g
• E23592380: VINTAGE ZR MARGIN LPM 15g
• E23592370: VINTAGE ZR MARGIN NM 15g
• E23592360: VINTAGE ZR MARGIN CLM 15g
• E23592330: VINTAGE ZR MARGIN D3M 15g
• E23592310: VINTAGE ZR MARGIN C4M 15g
• E23592290: VINTAGE ZR MARGIN C2M 15g
• E23592260: VINTAGE ZR MARGIN B4M 15g
• E23592240: VINTAGE ZR MARGIN B2M 15g
• E23592220: VINTAGE ZR MARGIN rootAM 15g
• E23592200: VINTAGE ZR MARGIN A3M 15g
• E23592180: VINTAGE ZR MARGIN W1M 15g
• E23592150: ZR CORRECTION CPM-FINE 15g
• E23592140: ZR CORRECTION ADD-ON T 15g
• E23592130: ZR CORRECTION ADD-ON B 15g
• E23592100: ZR GUM PORC GUM-DP 15g
• E23592090: ZR GUM PORC GUM-LP 15g
• E23592060: ZR COLOR EFFECTS W 15g
• E23592050: ZR COLOR EFFECTS G 15g
• E23592040: ZR COLOR EFFECTS O 15g
• E23592030: ZR COLOR EFFECTS Y 15g
• E23592020: ZR COLOR EFFECTS RED 15g
• E23592010: ZR COLOR EFFECTS MIv 15g
• E23592000: ZR COLOR EFFECTS MY 15g
• E23591990: ZR COLOR EFFECTS MP 15g
• E23591960: VINTAGE ZR TRANS CT-R 50g
• E23591950: VINTAGE ZR TRANS CT-B 50g
• E23591940: VINTAGE ZR TRANS CT-A 50g
• E23591930: VINTAGE ZR TRANS CT-W 50g
• E23591920: VINTAGE ZR TRANS CT-CL 50g
• E23591890: VINTAGE ZR TRANS CT-R 15g
• E23591880: VINTAGE ZR TRANS CT-B 15g
• E23591870: VINTAGE ZR TRANS CT-A 15g
• E23591860: VINTAGE ZR TRANS CT-W 15g
• E23591850: VINTAGE ZR TRANS CT-CL 15g
• E23591820: VINTAGE ZR CERVICAL DC 50g
• E23591810: VINTAGE ZR CERVICAL CC 50g
• E23591800: VINTAGE ZR CERVICAL BC 50g
• E23591790: VINTAGE ZR CERVICAL AC 50g
• E23591760: VINTAGE ZR CERVICAL DC 15g
• E23591750: VINTAGE ZR CERVICAL CC 15g
• E23591740: VINTAGE ZR CERVICAL BC 15g
• E23591730: VINTAGE ZR CERVICAL AC 15g
• E23591700: VINTAGE ZR ENAMAL T-GLASS EFFECT
• E23591690: VINTAGE ZR ENAMAL GT EFFECTS 5
• E23591680: VINTAGE ZR ENAMAL PT EFFECTS 5
• E23591670: VINTAGE ZR ENAMAL OT EFFECTS 5
• E23591660: VINTAGE ZR ENAMAL BT EFFECTS 5
• E23591630: VINTAGE ZR ENAMAL T-GLASS EFFECT
• E23591620: VINTAGE ZR ENAMAL GT EFFECTS 1