Burn-Out Cylinder BC4070B

GUDID 08806388211388

AnyOne Internal Ø4/ Bridge

Megagen Implant Co. Ltd

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08806388211388
• NIH Device Record Key: 3c84c21f-1f56-4edf-809b-1aaae47a59e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Burn-Out Cylinder
• Version Model Number: BC4070B
• Catalog Number: BC4070B
• Company DUNS: 687388178
• Company Name: Megagen Implant Co. Ltd
• 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: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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
GS1	08806388211388 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123988

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08806388211388]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2015-06-24

On-Brand Devices [Burn-Out Cylinder]

• 08806388211456: AnyOne Internal Ø6.5/ Single
• 08806388211449: AnyOne Internal Ø6.5/ Bridge
• 08806388211432: AnyOne Internal Ø5.5/ Single
• 08806388211425: AnyOne Internal Ø5.5/ Bridge
• 08806388211418: AnyOne Internal Ø4.5/ Single
• 08806388211395: AnyOne Internal Ø4/ Single
• 08806388211388: AnyOne Internal Ø4/ Bridge
• 08806388201006: AnyRidge Internal Ø7/ Single
• 08806388200993: AnyRidge Internal Ø6/ Single
• 08806388200986: AnyRidge Internal Ø5/ Single
• 08806388200979: AnyRidge Internal Ø4/ Single
• 08806388200962: AnyRidge Internal Ø7/ Bridge
• 08806388200955: AnyRidge Internal Ø6/ Bridge
• 08806388200948: AnyRidge Internal Ø5/ Bridge
• 08806388200931: AnyRidge Internal Ø4/ Bridge
• 08806388211401: AnyOne Internal Implant System Ø4.5/ Bridge