GC METALPRIMER II 000554

GUDID 24548161297346

GC METALPRIMER II Kit 5 mL liquid & 1 brush

Gc America Inc.

Dental etching solution

Primary Device ID	24548161297346
NIH Device Record Key	8b249f59-d701-4917-b8ed-33186a793ed0
Commercial Distribution Status	In Commercial Distribution
Brand Name	GC METALPRIMER II
Version Model Number	000554
Catalog Number	000554
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
Phone	+1(708)597-0900
Email	customerservice@gcamerica.com
Phone	+1(708)597-0900
Email	customerservice@gcamerica.com
Phone	+1(708)597-0900
Email	customerservice@gcamerica.com
Phone	+1(708)597-0900
Email	customerservice@gcamerica.com
Phone	+1(708)597-0900
Email	customerservice@gcamerica.com
Phone	+1(708)597-0900
Email	customerservice@gcamerica.com
Phone	+1(708)597-0900
Email	customerservice@gcamerica.com
Phone	+1(708)597-0900
Email	customerservice@gcamerica.com
Phone	+1(708)597-0900
Email	customerservice@gcamerica.com
Phone	+1(708)597-0900
Email	customerservice@gcamerica.com
Phone	+1(708)597-0900
Email	customerservice@gcamerica.com
Phone	+1(708)597-0900
Email	customerservice@gcamerica.com

Device Dimensions

Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter

Operating and Storage Conditions

Storage Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	14548161297349 [Primary]
GS1	24548161297346 [Package] Contains: 14548161297349 Package: Carton [5 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K972594

FDA Product Code

KLE	AGENT, TOOTH BONDING, RESIN

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	2022-08-29
Device Publish Date	2022-08-19

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D0470101184 - G-CEM LinkForce™	2025-03-17 G-CEM LinkForce™ Starter Kit A2, 1 LinkForce syringe (8.7g), 1 bottle G-Premio Bond 5mL, 1 bottle G-Multi Primer 5mL, 20 regul
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