BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

LITE ART

DI: E23519760 · Model: 1976 · SHOFU DENTAL CORPORATION

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Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

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Basic Information

Brand Name: LITE ART
Primary DI: E23519760
Version / Model: 1976
Catalog Number: 1976
Company Name: SHOFU DENTAL CORPORATION
Labeler DUNS: 054618202
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2016-09-23
Public Version: 3
Public Version Date: 2018-07-06
Public Version Status: Update
Public Device Record Key: 4225ca14-4591-455b-aeea-4b7843282676

Device Description

LITE ART KAHAKI

Device Characteristics

Single Use: No
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
EBF	Material, Tooth Shade, Resin	Dental	872.3690	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34771	Dental unfilled resin sealant/coating	A non-sterile, resin-based dental material intended for professional use as a sealant, coating, and/or glazing material during dental restoration (e.g., pit/fissure sealing and/or restorative composite resin sealing/coating), whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of an unfilled resin; it does not include any significant inorganic filler materials and is therefore not classed as a composite resin. It may be preloaded into an applicator. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	E23519760	HIBCC

Customer Contacts

Phone: 760-566-3528
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K101621	000

Storage Conditions

Type: Storage Environment Temperature
Temperature Range: 1 – 25 Degrees Celsius
Type: Handling Environment Temperature
Temperature Range: 1 – 25 Degrees Celsius