BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

Glidewell Zirconia Primer

DI: D745701198PVC00041 · Model: 70-1198-PVC0004 · Prismatik Dentalcraft, Inc

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Product Codes

1

GMDN Terms

1

Identifiers

2

Pkg Device Count

2

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Basic Information

Brand Name: Glidewell Zirconia Primer
Primary DI: D745701198PVC00041
Version / Model: 70-1198-PVC0004
Catalog Number: 70-1198-PVC00040
Company Name: Prismatik Dentalcraft, Inc
Labeler DUNS: 022761689
Distribution Status: In Commercial Distribution
Device Count in Pkg: 2
Record Status: Published
Publish Date: 2022-07-19
Public Version: 2
Public Version Date: 2023-08-22
Public Version Status: Update
Public Device Record Key: e61bae3a-468f-4dd9-9686-14b811048bef

Device Description

Glidewell Zirconia Primer 2X0.1ml

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
KLE	AGENT, TOOTH BONDING, RESIN	Dental	872.3200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62474	Dental prosthesis priming agent	A material primarily intended to be applied to a dental prosthesis (i.e., indirect restorative) and/or prosthesis component to promote bonding (e.g., to a composite resin cement, composite-based stain, or another prosthesis component). It may be referred to as a primer and includes compounds such as an unfilled-resin or silane-based agent; an applicator may also be included. The material is not intended to be used as a dentine bonding or dentine priming agent. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	D745701198PVC00040	HIBCC
Primary	D745701198PVC00041	HIBCC

Customer Contacts

Phone: +1(800)854-7256
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K221033	000