ET RIGID IMPRESSION COPING

GUDID 00810125991226

HIOSSEN, INC.

Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 00810125991226
• NIH Device Record Key: 39128026-134b-46b6-9dbb-0f5b46897df8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ET RIGID IMPRESSION COPING
• Version Model Number: ETRIC460SC
• Company DUNS: 796083090
• Company Name: HIOSSEN, 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810125991226 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222636

FDA Product Code

• NDP: Accessories, Implant, Dental, Endosseous

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: 2024-07-11
• Device Publish Date: 2024-07-03

On-Brand Devices [ET RIGID IMPRESSION COPING]

• 00810019240478: ETRIC7005S
• 00810019240461: ETRIC6007S
• 00810019240454: ETRIC6005S
• 00810019240447: ETRIC6004S
• 00810019240430: ETRIC5007S
• 00810019240423: ETRIC5005S
• 00810019240416: ETRIC5004S
• 00810019240409: ETRIC4507S
• 00810019240393: ETRIC4505S
• 00810019240386: ETRIC4504S
• 00810019240379: ETRIC4007S
• 00810019240362: ETRIC4005S
• 00810019240355: ETRIC4004S
• 00810125991332: ETRIC760SC
• 00810125991325: ETRIC670SC
• 00810125991318: ETRIC660SC
• 00810125991301: ETRIC640SC
• 00810125991295: ETRIC570SC
• 00810125991288: ETRIC560SC
• 00810125991271: ETRIC540SC
• 00810125991264: ETRIC471SC
• 00810125991257: ETRIC461SC
• 00810125991240: ETRIC441SC
• 00810125991233: ETRIC470SC
• 00810125991226: ETRIC460SC
• 00810125991219: ETRIC440SC