G-CEM LinkForce™ 009548

GUDID D0470095484

G-CEM Link Force™ Try-In Paste A2, 1 syringe (1.5g/1.2mL)

Gc America Inc.

Dental cement trial

• Primary Device ID: D0470095484
• NIH Device Record Key: 31fa1e5e-1773-4e5c-9829-5388bb53a1cd
• Commercial Distribution Discontinuation: 2020-02-05
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: G-CEM LinkForce™
• Version Model Number: 009548
• Catalog Number: 009548
• Company DUNS: 005473608
• Company Name: Gc America Inc.
• 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: +1(708)597-0900
• Email: customerservice@gcamerica.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D0470095481 [Primary]
HIBCC	D0470095484 [Package]; Contains: D0470095481; Package: Carton [30 Units]; Discontinued: 2020-02-05; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153231

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: 5
• Public Version Date: 2020-02-11
• Device Publish Date: 2016-10-20

On-Brand Devices [G-CEM LinkForce™]

• D0470095514: G-CEM LinkForce™ Try-In Paste Bleach, 1 syringe (1.5g/1.2mL)
• D0470095504: G-CEM LinkForce™ Try-In Paste Opaque 1 syringe (1.5g/1.2mL)
• D0470095494: G-CEM LinkForce™ Try-In Paste Translucent 1 syringe (1.5g/1.2mL)
• D0470095484: G-CEM Link Force™ Try-In Paste A2, 1 syringe (1.5g/1.2mL)
• 14548161292504: G-CEM Try-In Paste Bleach Refill Syringe, 3 disensing tips (metal type), 1 tip cover
• 14548161292498: G-CEM Try-In Paste Opaque Refill Syringe, 3 dispensing tips (metal type), 1 tip cover
• 14548161292481: G-CEM Try-In Paste Translucent Refill Syringe, 3 Dispensing tips (metal type) 1 tip cover
• 14548161292474: G-CEM Try-In Paste A2 Refill Syringe, 3 dispensing tips (metal type), 1 tip cover
• 44548161321892: G-CEM LinkForce™ Cement Refill Bleach, 1 syringe (8.7g/5mL) 20 regular mixing tips
• 44548161321885: G-CEM LinkForce™ Cement Refill Opaque, 1 syringe (8.7g/5mL), 20 regular mixing tips
• 44548161321878: G-CEM LinkForce™ Cement Refill Translucent, 1 syringe (8.7g/5mL), 20 regular mixing tips
• 44548161321861: G-CEM LinkForce™ Cement Refill A2, 1 syringe (8.7g/5mL), 20 regular mixing tips
• 44548161321854: G-CEM LinkForce™ Starter Kit Translucent, 1 LinkForce syringe (8.7g), 1 bottle G-Premio Bond 5
• 44548161321847: G-CEM LinkForce™ Starter Kit A2, 1 LinkForce syringe (8.7g), 1 bottle G-Premio Bond 5mL, 1 bot
• 44548161321830: G-CEM LinkForce™ System Kit 3 LinkForce syringes (8.7g) one each of A2, Translucent Opaque, 45