Grandio blocs 6159

GUDID E22161590

5x Gr. 12 BL LT (Low Translucent)

VOCO GmbH

Temporary dental crown/bridge

• Primary Device ID: E22161590
• NIH Device Record Key: 136eb047-5b68-4b60-a0ec-667fa108b610
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Grandio blocs
• Version Model Number: 6159
• Catalog Number: 6159
• Company DUNS: 316699578
• Company Name: VOCO GmbH
• 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: 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

Customer Support Contacts

• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E22161590 [Unit of Use]
HIBCC	E22161591 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171200

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: 2022-01-27
• Device Publish Date: 2022-01-19

On-Brand Devices [Grandio blocs]

• E22160341: 1 each of A1 LT, B1 LT, C2 LT, BL LT, A1 HT
• E22160331: 1 each of A1 LT, B1 LT, C2 LT, BL LT, A1 HT
• E22160301: A3.5 HT (High translucent)
• E22160291: A3 HT (High translucent)
• E22160281: A2 HT (High translucent)
• E22160271: A1 HT (High translucent)
• E22160241: BL LT (Low translucent)
• E22160231: C2 LT (Low translucent)
• E22160221: B1 LT (Low translucent)
• E22160211: A3.5 LT (Low translucent)
• E22160201: A3 LT (Low translucent)
• E22160191: A2 LT (Low translucent)
• E22160181: A1 LT (Low translucent)
• E22160151: A3.5 HT (High translucent)
• E22160141: A3 HT (High translucent)
• E22160131: A2 HT (High translucent)
• E22160121: A1 HT (High translucent)
• E22160091: BL LT (Low Translucent)
• E22160081: C2 LT (Low Translucent)
• E22160071: B1 LT (Low Translucent)
• E22160061: A3.5 LT (Low Translucent)
• E22160051: A3 LT (Low Translucent)
• E22160041: A2 LT (Low Translucent)
• E22160031: A1 LT (Low Translucent)
• E22160001: Set blocks 2 × No. 12 (A2 LT, A3 HT), 3 × No. 14L (A3 LT, A3 HT, A3.5 LT), Bifix QM QuickMix s
• E22161840: 1x A1 LT/14L, 1xB1 LT/14L, 1xC2 LT/14L, 1xBL LT/14L, 1x A1 HT/14L
• E22161830: 1x A1 LT/12, 1xB1 LT/12, 1xC2 LT/12, 1xBL LT/12, 1x A1 HT/12
• E22161800: 5x Gr. 14L A3.5 HT (HighTranslucent)
• E22161790: 5x Gr. 14L A3 HT (HighTranslucent)
• E22161780: 5x Gr. 14L A2 HT (HighTranslucent)
• E22161770: 5x Gr. 14L A1 HT (HighTranslucent)
• E22161740: 5x Gr. 14L BL LT (Low Translucent)
• E221617130: 5x Gr. 14L C2 LT (Low Translucent)
• E221617120: 5x Gr. 14L B1 LT (Low Translucent)
• E22161710: 5x Gr. 14L A3.5 LT (Low Translucent)
• E22161700: 5x Gr. 14L A3 LT (Low Translucent)
• E22161690: 5x Gr. 14L A2 LT (Low Translucent)
• E22161680: 5x Gr. 14L A1 LT (Low Translucent)
• E22161650: 5x Gr. 12 A3.5 HT (High Translucent)
• E22161640: 5x Gr. 12 A3 HT (High Translucent)
• E22161630: 5x Gr. 12 A2 HT (High Translucent)
• E22161620: 5x Gr. 12 A1 HT (High Translucent)
• E22161590: 5x Gr. 12 BL LT (Low Translucent)
• E22161580: 5x Gr. 12 C2 LT (Low Translucent)
• E22161570: 5x Gr. 12 B1 LT (Low Translucent)
• E22161560: 5x Gr. 12 A3.5 LT (Low Translucent)
• E22161550: 5x Gr. 12 A3 LT (Low Translucent)
• E22161540: 5x Gr. 12 A2 LT (Low Translucent)
• E22161530: 5x Gr. 12 A1 LT (Low Translucent)