CERASMART®

Basic Information

• Brand Name: CERASMART®
• Primary DI: D0470119501
• Version / Model: 011950
• Catalog Number: 011950
• Company Name: Gc America Inc.
• Labeler DUNS: 005473608
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2017-10-16
• Public Version: 8
• Public Version Date: 2021-10-01
• Public Version Status: Update
• Public Device Record Key: 7bd89361-050a-4229-acf8-80bf34792ea0
• Distribution End Date: 2021-10-01

Device Description

CERASMART® Glidewell 14 A1 HT 5p Block

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EBG	CROWN AND BRIDGE, TEMPORARY, RESIN	Dental	872.3770	2
EBF	MATERIAL, TOOTH SHADE, RESIN	Dental	872.3690	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44879	Dental implant suprastructure, permanent, preformed	A prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D0470119501	HIBCC
Unit of Use	D0470119500	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K133824	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 39 – 77 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 4 – 25 Degrees Celsius