EX-3 PRESS LF

GUDID EKUR1081073KA0

nC3B 200g

KURARAY NORITAKE DENTAL INC.

Dental appliance fabrication material, ceramic

• Primary Device ID: EKUR1081073KA0
• NIH Device Record Key: 380ffd77-32b6-4970-883e-cea0181a76d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EX-3 PRESS LF
• Version Model Number: 108-1073KA
• Company DUNS: 697119498
• Company Name: KURARAY NORITAKE DENTAL 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EKUR1081073KA0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052304

FDA Product Code

• EIH: Powder, Porcelain

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-24
• Device Publish Date: 2017-02-17

On-Brand Devices [EX-3 PRESS LF]

• EKUR1082011KA0: MRP 10g
• EKUR1081991KA0: Internal Stain Bright 3g
• EKUR1081981KA0: Internal Stain Fluoro 3g
• EKUR1081971KA0: Internal Stain D+ 3g
• EKUR1081961KA0: Internal Stain C+ 3g
• EKUR1081951KA0: Internal Stain B+ 3g
• EKUR1081941KA0: Internal Stain A+ 3g
• EKUR1081931KA0: Internal Stain Salmon Pink 3g
• EKUR1081921KA0: Internal Stain Red 3g
• EKUR1081911KA0: Internal Stain Reddish Brown 3g
• EKUR1081901KA0: Internal Stain Earth Brown 3g
• EKUR1081891KA0: Internal Stain Cervical 3 3g
• EKUR1081881KA0: Internal Stain Cervical 2 3g
• EKUR1081871KA0: Internal Stain Cervical 1 3g
• EKUR1081861KA0: Internal Stain Mamelon Orange 2 3g
• EKUR1081851KA0: Internal Stain Mamelon Orange 1 3g
• EKUR1081841KA0: Internal Stain Incisal Blue 2 3g
• EKUR1081831KA0: Internal Stain Incisal Blue 1 3g
• EKUR1081821KA0: Internal Stain Gray 3g
• EKUR1081811KA0: Internal Stain White 3g
• EKUR1081804KA0: External Stain Glaze 30g
• EKUR1081801KA0: External Stain Glaze 10g
• EKUR1081791KA0: External Stain D+ 3g
• EKUR1081781KA0: External Stain C+ 3g
• EKUR1081771KA0: External Stain B+ 3g
• EKUR1081761KA0: External Stain A+ 3g
• EKUR1081751KA0: External Stain Red 3g
• EKUR1081741KA0: External Stain Pink 3g
• EKUR1081731KA0: External Stain Salmon Pink 3g
• EKUR1081721KA0: External Stain Reddish Brown 3g
• EKUR1081711KA0: External Stain Earth Brown 3g
• EKUR1081701KA0: External Stain Cervical 3 3g
• EKUR1081691KA0: External Stain Cervical 2 3g
• EKUR1081681KA0: External Stain Cervical 1 3g
• EKUR1081671KA0: External Stain Yellow 3g
• EKUR1081661KA0: External Stain Orange 2 3g
• EKUR1081651KA0: External Stain Orange 1 3g
• EKUR1081641KA0: External Stain Green 2 3g
• EKUR1081631KA0: External Stain Green 1 3g
• EKUR1081621KA0: External Stain Blue 3g
• EKUR1081611KA0: External Stain Black 3g
• EKUR1081601KA0: External Stain Pure White 3g
• EKUR1081591KA0: External Stain Gray 3g
• EKUR1081582KA0: AD-T 50g
• EKUR1081581KA0: AD-T 10g
• EKUR1081572KA0: AD-B 50g
• EKUR1081571KA0: AD-B 10g
• EKUR1081562KA0: Tissue 7 50g
• EKUR1081561KA0: Tissue 7 10g
• EKUR1081552KA0: Tissue 6 50g