Solidex 1648

GUDID E23516480

SOLIDEX BODY, B3, 4g

SHOFU DENTAL CORPORATION

Dental prosthesis veneer resin

• Primary Device ID: E23516480
• NIH Device Record Key: fde83b98-08d8-4581-978e-0fb02145975e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solidex
• Version Model Number: 1648
• Catalog Number: 1648
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E23516480 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K972292

FDA Product Code

• EBF: Material, Tooth Shade, Resin

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 [Solidex]

• E23516970: SOLIDEX BODY, BASE, 4g
• E23516940: SOLIDEX EFFECT WE, 4g
• E23516930: SOLIDEX EFFECT GUM,4g
• E23516920: SOLIDEX EFFECT AM, 4g
• E23516910: SOLIDEX EFFECT OC,4g
• E23516830: SOLIDEX TRANS, LVT, 4g
• E23516820: SOLIDEX TRANS, HVT, 4g
• E23516810: SOLIDEX TRANS, T, 4g
• E23516740: SOLIDEX INCISAL 60, 4g
• E23516730: SOLIDEX INCISAL 59, 4g
• E23516720: SOLIDEX INCISAL 58, 4g
• E23516710: SOLIDEX INCISAL 57, 4g
• E23516680: Solidex Cervical, 4g DC2
• E23516670: SOLIDEX CERVICAL, DC, 4g
• E23516660: Solidex Cervical, 4g CC2
• E23516650: SOLIDEX CERVICAL, CC, 4g
• E23516640: SOLIDEX CERVICAL, BC2, 4g
• E23516630: SOLIDEX CERVICAL, BC1, 4g
• E23516620: SOLIDEX CERVICAL, AC2, 4g
• E23516610: SOLIDEX CERVICAL, AC1, 4g
• E23516560: SOLIDEX BODY, D4, 4g
• E23516550: SOLIDEX BODY, D3, 4g
• E23516540: SOLIDEX BODY, D2, 4g
• E23516530: SOLIDEX BODY, C4, 4g
• E23516520: SOLIDEX BODY, C3, 4g
• E23516510: SOLIDEX BODY, C2, 4g
• E23516500: SOLIDEX BODY, C1, 4g
• E23516490: SOLIDEX BODY, B4, 4g
• E23516480: SOLIDEX BODY, B3, 4g
• E23516470: SOLIDEX BODY, B2, 4g
• E23516460: SOLIDEX BODY, B1, 4g
• E23516450: SOLIDEX BODY, A4, 4g
• E23516440: SOLIDEX BODY, A3.5, 4g
• E23516430: SOLIDEX BODY, A3, 4g
• E23516420: SOLIDEX BODY, A2, 4g
• E23516410: SOLIDEX BODY, A1, 4g
• E23516300: Solidex Paste Opaque, 2ml, PO
• E23516290: SOLIDEX OPAQUE, VrO, 2ML
• E23516280: SOLIDEX OPAQUE, VpO, 2ML
• E23516270: SOLIDEX OPAQUE, InO
• E23516260: Solidex Paste Opaque, 2ml D4O
• E23516250: SOLIDEX OPAQUE, D3, 2ML
• E23516240: SOLIDEX OPAQUE, D2, 2ML
• E23516230: Solidex Paste Opaque, 2ml C4O
• E23516220: SOLIDEX OPAQUE, C3, 2ML
• E23516210: SOLIDEX OPAQUE, C2, 2ML
• E23516200: Solidex Paste Opaque, 2ml C1O
• E23516190: SOLIDEX OPAQUE, B4, 2ML
• E23516180: SOLIDEX OPAQUE, B3, 2ML
• E23516170: SOLIDEX OPAQUE, B2, 2ML