Solera 6208

GUDID EWOH62081

Solera Opak-Dentin C2 1onz

WOHLWEND AG DENTAL MANUFAKTUR

Dental appliance fabrication material, ceramic

• Primary Device ID: EWOH62081
• NIH Device Record Key: 0b07b2b3-99f7-4ec2-ab28-932188d970a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solera
• Version Model Number: 6208
• Catalog Number: 6208
• Company DUNS: 448037775
• Company Name: WOHLWEND AG DENTAL MANUFAKTUR
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EWOH62081 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K990790

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: 3
• Public Version Date: 2019-11-04
• Device Publish Date: 2018-10-11

On-Brand Devices [Solera]

• EWOH64311: Solera Shoulderliquid 250ml
• EWOH64301: Solera Shoulerliquid 50ml
• EWOH64291: Solera Shoulderliquid 25ml
• EWOH64281: Solera Glasurliquid 250ml
• EWOH64271: Solera Glasurliquid 50ml
• EWOH64261: Solera Glasurliquid 25ml
• EWOH64251: Solera Opaquerliquid 250ml
• EWOH64241: Solera Opaquerliquid 50ml
• EWOH64231: Solera Opaquerliquid 25ml
• EWOH64221: Solera Modellierliquid 250ml
• EWOH64211: Solera Modellierliquid 50ml
• EWOH64201: Solera Modellierliquid 25ml
• EWOH63441: Solera Shoulder Neutral 4onz
• EWOH63431: Solera Shoulder Neutral 1onz
• EWOH63411: Solera Shoulder D 4onz
• EWOH63401: Solera Shoulder D 1onz
• EWOH63381: Solera Shoulder C 4onz
• EWOH63371: Solera Shoulder C 1onz
• EWOH63351: Solera Shoulder B 4onz
• EWOH63341: Solera Shoulder B 1onz
• EWOH63321: Solera Shoulder A 4onz
• EWOH63311: Solera Shoulder A 1onz
• EWOH63291: Solera Croma Dentin Neon 4onz
• EWOH63281: Solera Croma Dentin Neon 1onz
• EWOH63261: Solera Croma Dentin D 4onz
• EWOH63251: Solera Croma Dentin D 1onz
• EWOH63231: Solera Croma Dentin C 4onz
• EWOH63221: Solera Croma Dentin C 1onz
• EWOH63201: Solera Croma Dentin B 4onz
• EWOH63191: Solera Croma Dentin B 1onz
• EWOH63171: Solera Croma Dentin A 4onz
• EWOH63161: Solera Croma Dentin A 1onz
• EWOH63141: Solera Glaze 4onz
• EWOH63131: Solera Glaze 1onz
• EWOH63111: Solera TR-Gray 4onz
• EWOH63101: Solera TR-Gray 1onz
• EWOH63081: Solera TR-Yellow 4onz
• EWOH63071: Solera TR-Yellow 1onz
• EWOH63051: Solera TR-Red 4onz
• EWOH63041: Solera TR-Red 1onz
• EWOH63021: Solera TR-Light-blue 4onz
• EWOH63011: Solera TR-Light-blue 1onz
• EWOH62991: Solera TR-White 4onz
• EWOH62981: Solera TR-White 1onz
• EWOH62961: Solera TR-Opal 4onz
• EWOH62951: Solera TR-Opal 1onz
• EWOH62931: Solera TR-Neutral 4onz
• EWOH62921: Solera TR-Neutral 1onz
• EWOH62901: Solera TR-Superclear 4onz
• EWOH62891: Solera TR-Superclear 1onz