EX-3 PRESS LF

GUDID EKUR1081362KA0

LT Yellow 50g

KURARAY NORITAKE DENTAL INC.

Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic

• Primary Device ID: EKUR1081362KA0
• NIH Device Record Key: 3192e11c-d0c2-4904-90a3-c2db451ea39b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EX-3 PRESS LF
• Version Model Number: 108-1362KA
• 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	EKUR1081362KA0 [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