CZR PRESS LF

GUDID EKUR1071083KA0

Silky E1 200g

KURARAY NORITAKE DENTAL INC.

Dental appliance fabrication material, ceramic

• Primary Device ID: EKUR1071083KA0
• NIH Device Record Key: c9b3b505-6b67-4f06-88c6-3188a1a399da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CZR PRESS LF
• Version Model Number: 107-1083KA
• 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	EKUR1071083KA0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043462

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 [CZR PRESS LF]

• EKUR1071851KA0: MRP 10g
• EKUR1071841KA0: Internal Stain Bright 3g
• EKUR1071831KA0: Internal Stain Fluoro 3g
• EKUR1071821KA0: Internal Stain D+ 3g
• EKUR1071811KA0: Internal Stain C+ 3g
• EKUR1071801KA0: Internal Stain B+ 3g
• EKUR1071791KA0: Internal Stain A+ 3g
• EKUR1071781KA0: Internal Stain Salmon Pink 3g
• EKUR1071771KA0: Internal Stain Red 3g
• EKUR1071761KA0: Internal Stain Reddish Brown 3g
• EKUR1071751KA0: Internal Stain Earth Brown 3g
• EKUR1071741KA0: Internal Stain Cervical 3 3g
• EKUR1071731KA0: Internal Stain Cervical 2 3g
• EKUR1071721KA0: Internal Stain Cervical 1 3g
• EKUR1071711KA0: Internal Stain Mamelon Orange 2 3g
• EKUR1071701KA0: Internal Stain Mamelon Orange 1 3g
• EKUR1071691KA0: Internal Stain Incisal Blue2 3g
• EKUR1071681KA0: Internal Stain Incisal Blue1 3g
• EKUR1071671KA0: Internal Stain Gray 3g
• EKUR1071661KA0: Internal Stain White 3g
• EKUR1071651KA0: External Stain Glaze 10g
• EKUR1071641KA0: External Stain D+ 3g
• EKUR1071631KA0: External Stain C+ 3g
• EKUR1071621KA0: External Stain B+ 3g
• EKUR1071611KA0: External Stain A+ 3g
• EKUR1071601KA0: External Stain Red 3g
• EKUR1071591KA0: External Stain Pink 3g
• EKUR1071581KA0: External Stain Salmon Pink 3g
• EKUR1071571KA0: External Stain Reddish Brown 3g
• EKUR1071561KA0: External Stain Earth Brown 3g
• EKUR1071551KA0: External Stain Cervical 3 3g
• EKUR1071541KA0: External Stain Cervical 2 3g
• EKUR1071531KA0: External Stain Cervical 1 3g
• EKUR1071521KA0: External Stain Yellow 3g
• EKUR1071511KA0: External Stain Orange 2 3g
• EKUR1071501KA0: External Stain Orange 1 3g
• EKUR1071491KA0: External Stain Green 2 3g
• EKUR1071481KA0: External Stain Green 1 3g
• EKUR1071471KA0: External Stain Blue 3g
• EKUR1071461KA0: External Stain Black 3g
• EKUR1071451KA0: External Stain Pure White 3g
• EKUR1071441KA0: External Stain Gray 3g
• EKUR1071432KA0: AD-T 50g
• EKUR1071431KA0: AD-T 10g
• EKUR1071422KA0: AD-B 50g
• EKUR1071421KA0: AD-B 10g
• EKUR1071412KA0: Tissue 7 50g
• EKUR1071411KA0: Tissue 7 10g
• EKUR1071402KA0: Tissue 6 50g
• EKUR1071401KA0: Tissue 6 10g