CERASMART™ 012460

GUDID 04548161320446

CERASMART™ 270 14 Universal B1 HT 5p Block

Gc America Inc.

Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed

• Primary Device ID: 04548161320446
• NIH Device Record Key: 6ce010ac-958d-4bd1-9cc4-865f2eac9c3c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CERASMART™
• Version Model Number: 012460
• Catalog Number: 012460
• Company DUNS: 005473608
• Company Name: Gc America Inc.
• Device Count: 5
• 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: true
• 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

Customer Support Contacts

• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04548161320446 [Unit of Use]
GS1	14548161320443 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133824

FDA Product Code

• EBF: Material, tooth shade, resin

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-15
• Device Publish Date: 2022-08-05

On-Brand Devices [CERASMART™]

• 04548161320965: CERASMART™ 270 14L Universal A3.5 LT 5p Block
• 04548161320958: CERASMART™ 270 14L Universal A3 LT 5p Block
• 04548161320941: CERASMART™ 270 14L Universal A2 LT 5p Block
• 04548161320927: CERASMART™ 270 14L Universal B1 HT 5p Block
• 04548161320910: CERASMART™ 270 14L Universal A3.5 HT 5p Block
• 04548161320859: CERASMART™ 270 14L Universal A3 HT 5p Block
• 04548161320743: CERASMART™ 270 14L Universal A2 HT 5p Block
• 04548161320651: CERASMART™ 270 14L Universal BL 5p Block
• 04548161320644: CERASMART™ 270 14L Universal B1 LT 5p Block
• 04548161320637: CERASMART™ 270 14L Universal A1 HT 5p Block
• 04548161320620: CERASMART™ 270 14L Cerec BL 5p Block
• 04548161320613: CERASMART™ 270 14L Cerec B1 LT 5p Block
• 04548161320606: CERASMART™ 270 14L Cerec A3.5 LT 5p Block
• 04548161320590: CERASMART™ 270 14L Cerec A3 LT 5p Block
• 04548161320583: CERASMART™ 270 14L Cerec A2 LT 5p Block
• 04548161320576: CERASMART™ 270 14L Cerec A1 LT 5p Block
• 04548161320569: CERASMART™ 270 14L Cerec B1 HT 5p Block
• 04548161320552: CERASMART™ 270 14L Cerec A3.5 HT 5p Block
• 04548161320545: CERASMART™ 270 14L Cerec A3 HT 5p Block
• 04548161320538: CERASMART™ 270 14L Cerec A2 HT 5p Block
• 04548161320514: CERASMART™ 270 14L Cerec A1 HT 5p Block
• 04548161320507: CERASMART™ 270 14 Universal BL 5p Block
• 04548161320491: CERASMART™ 270 14 Universal B1 LT 5p Block
• 04548161320484: CERASMART™ 270 14 Universal A3.5 LT 5p Block
• 04548161320477: CERASMART™ 270 14 Universal A3 LT 5p Block
• 04548161320460: CERASMART™ 270 14 Universal A2 LT 5p Block
• 04548161320453: CERASMART™ 270 14 Universal A1 LT 5p Block
• 04548161320446: CERASMART™ 270 14 Universal B1 HT 5p Block
• 04548161320439: CERASMART™ 270 14 Universal A3.5HT 5p Block
• 04548161320422: CERASMART™ 270 14 Universal A3 HT 5p Block
• 04548161320408: CERASMART™ 270 14 Universal A2 HT 5p Block
• 04548161320392: CERASMART™ 270 14 Universal A1 HT 5p Block
• 04548161320385: CERASMART™ 270 14 Cerec BL 5p Block
• 04548161320378: CERASMART™ 270 14 Cerec B1 LT 5p Block
• 04548161320361: CERASMART™ 270 14 Cerec A3.5 LT 5p Block
• 04548161320354: CERASMART™ 270 14 Cerec A3 LT 5p Block
• 04548161320347: CERASMART™ 270 14 Cerec A2 LT 5p Block
• 04548161320330: CERASMART™ 270 14 Cerec A1 LT 5p Block
• 04548161320323: CERASMART™ 270 14 Cerec B1 HT 5p Block
• 04548161320316: CERASMART™ 270 14 Cerec A3.5 HT 5p Block
• 04548161320293: CERASMART™ 270 14 Cerec A3 Ht 5p Block
• 04548161320286: CERASMART™ 270 14 Cerec A2 HT 5p Block
• 04548161320279: CERASMART™ 270 14 Cerec A1 HT 5p Block
• 04548161320262: CERASMART™ 270 12 Universal BL 5p Block
• 04548161320255: CERASMART™ 270 12 Universal B1 LT 5p Block
• 04548161320248: CERASMART™ 270 12 Universal A3.5 LT 5p Block
• 04548161320231: CERASMART™ 270 12 Universal A3 LT 5p Block
• 04548161320224: CERASMART™ 270 12 Universal A2 LT 5p Block
• 04548161320217: CERASMART™ 270 12 Universal A1 LT 5p Block
• 04548161320200: CERASMART™ 270 12 Universal B1 HT 5p Block