Impression Coping IT5512N

GUDID 08806388223664

AnyOne Internal Ø5.5/ L=12/ Non-Hex/ Transfer

Megagen Implant Co. Ltd

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08806388223664
• NIH Device Record Key: 2c087f4a-3e49-47fd-bed0-7b241994d0f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Impression Coping
• Version Model Number: IT5512N
• Catalog Number: IT5512N
• 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	08806388223664 [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

[08806388223664]

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: 2015-06-25

On-Brand Devices [Impression Coping]

• 08806388239696: ExFeel External Ø5.8/ L=12/ Hex/ Pick-up/ Wide
• 08806388239689: ExFeel External Ø5.8/ L=12/ Hex/ Pick-up/ Wide
• 08806388239597: ExFeel External Ø5.8/ L=13/ Non-Hex/ Transfer/ Wide
• 08806388239580: ExFeel External Ø5.8/ L=13/ Hex/ Transfer/ Wide
• 08806388235827: ExFeel External M1.6/ Pick-up/ Hex
• 08806388235537: ExFeel External Ø4.8/ L=13/ Non-Hex/ Transfer/ Small
• 08806388235520: ExFeel External Ø4.8/ L=13/ Hex/ Transfer/ Small
• 08806388232918: ExFeel External Ø6/ L=12/ Non-Hex/ Pick-up
• 08806388232901: ExFeel External Ø5/ L=12/ Non-Hex/ Pick-up
• 08806388232895: ExFeel External Ø6/ L=12/ Hex/ Pick-up
• 08806388232888: ExFeel External Ø5/ L=12/ Hex/ Pick-up
• 08806388232871: ExFeel External Ø5/ L=12/ Hex/ Pick-up
• 08806388232826: Rescue External Ø5.5/ L=8/ Transfer/ Widecone
• 08806388232819: ExFeel External Ø4.5/ L=9/ Transfer/ Standard
• 08806388232802: ExFeel External Ø4.8/ L=8/ Transfer/ Esthetic
• 08806388232796: ExFeel External Ø4.8/ L=10/ Non-Octa/ Pick-up
• 08806388232789: ExFeel External Ø4.8/ L=10/ Octa/ Pick-up
• 08806388232758: ExFeel External Non-Hex/ Pick-up/ Esthetic
• 08806388232741: ExFeel External Hex/ Pick-up/ Esthetic
• 08806388232567: ExFeel External Ø4.8/ L=13/ Non-Hex/ Transfer/ Regular
• 08806388232550: ExFeel External Ø4.8/ L=13/ Non-Trip/ Transfer
• 08806388232543: ExFeel External Ø4.8/ L=13/ Hex/ Transfer/ Regular
• 08806388232536: ExFeel External Ø4.8/ L=13/ Trip/ Transfer
• 08806388227099: MiNi Internal Ø3.5/ L=16/ Non-Hex/ Transfer
• 08806388227082: MiNi Internal Ø3.5/ L=16/ Hex/ Transfer
• 08806388227075: MiNi Internal Ø3.5/ L=12/ Non-Hex/ Transfer
• 08806388227068: MiNi Internal Ø3.5/ L=12/ Hex/ Transfer
• 08806388227051: MiNi Internal Ø3.5/ L=16/ Non-Hex/ Pick-up
• 08806388227044: MiNi Internal Ø3.5/ L=16/ Hex/ Pick-up
• 08806388227037: MiNi Internal Ø3.5/ L=12/ Non-Hex/ Pick-up
• 08806388227020: MiNi Internal Ø3.5/ L=12/ Hex/ Pick-up
• 08806388225101: Rescue External Ø5.8/ L=12/ Non-Hex/ Pick-up
• 08806388225095: Rescue External Ø5.8/ L=12/ Hex/ Pick-up
• 08806388225064: Rescue External Ø5.8/ L=13/ Non-Hex/ Transfer
• 08806388225057: Rescue External Ø5.8/ L=13/ Hex/ Transfer
• 08806388223787: AnyOne Internal Ø6.5/ L=16/ Non-Hex/ Transfer
• 08806388223770: AnyOne Internal Ø6.5/ L=16/ Non-Hex/ Transfer
• 08806388223763: AnyOne Internal Ø6.5/ L=16/ Hex/ Transfer
• 08806388223749: AnyOne Internal Ø6.5/ L=12/ Non-Hex/ Transfer
• 08806388223732: AnyOne Internal Ø6.5/ L=12/ Non-Hex/ Transfer
• 08806388223725: AnyOne Internal Ø6.5/ L=12/ Hex/ Transfer
• 08806388223701: AnyOne Internal Ø5.5/ L=16/ Non-Hex/ Transfer
• 08806388223695: AnyOne Internal Ø5.5/ L=16/ Non-Hex/ Transfer
• 08806388223688: AnyOne Internal Ø5.5/ L=16/ Hex/ Transfer
• 08806388223664: AnyOne Internal Ø5.5/ L=12/ Non-Hex/ Transfer
• 08806388223657: AnyOne Internal Ø5.5/ L=12/ Non-Hex/ Transfer
• 08806388223640: AnyOne Internal Ø5.5/ L=12/ Hex/ Transfer
• 08806388223626: AnyOne Internal Ø4.5/ L=16/ Non-Hex/ Transfer
• 08806388223619: AnyOne Internal Ø4.5/ L=16/ Non-Hex/ Transfer
• 08806388223602: AnyOne Internal Ø4.5/ L=16/ Hex/ Transfer