ET RIGID PROTECT CAP

GUDID 00810125990953

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 Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 00810125990953
• NIH Device Record Key: b4323c78-a8d7-4857-b6e2-b41d69cffb8b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ET RIGID PROTECT CAP
• Version Model Number: ETRPC440C
• 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	00810125990953 [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: 2024-07-05
• Device Publish Date: 2024-06-27

On-Brand Devices [ET RIGID PROTECT CAP]

• 00810019240218: ETRPC7005S
• 00810019240201: ETRPC6007S
• 00810019240195: ETRPC6005S
• 00810019240188: ETRPC6004S
• 00810019240171: ETRPC5007S
• 00810019240164: ETRPC5005S
• 00810019240157: ETRPC5004S
• 00810019240140: ETRPC4507
• 00810019240133: ETRPC4505
• 00810019240126: ETRPC4504
• 00810019240119: ETRPC4007
• 00810019240102: ETRPC4005
• 00810019240096: ETRPC4004
• 00810125991066: ETRPC670C
• 00810125991073: ETRPC760C
• 00810125991059: ETRPC660C
• 00810125991035: ETRPC570C
• 00810125991028: ETRPC560C
• 00810125991011: ETRPC540C
• 00810125991004: ETRPC471C
• 00810125990991: ETRPC461C
• 00810125990977: ETRPC470C
• 00810125990960: ETRPC460C
• 00810125990953: ETRPC440C
• 00810125991042: ETRPC640C
• 00810125990984: ETRPC441C