ET FIXTURE PICK-UP IMPRESSION COPING

GUDID 00810125994821

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: 00810125994821
• NIH Device Record Key: 4bad3759-291c-4827-9bdf-118ff6032742
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ET FIXTURE PICK-UP IMPRESSION COPING
• Version Model Number: ETPIS5015CA
• 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	00810125994821 [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: 2024-07-01
• Device Publish Date: 2024-06-21

On-Brand Devices [ET FIXTURE PICK-UP IMPRESSION COPING]

• 00814913026022: ETFPI5020MH
• 00814913026015: ETFPI4020MH
• 00814913025629: ETFPI7015SN
• 00814913025612: ETFPI6015SN
• 00814913025605: ETFPI5015SN
• 00814913025599: ETFPI4515SN
• 00814913025582: ETFPI4015SN
• 00814913025575: ETFPI4515MN
• 00814913025568: ETFPI4015MN
• 00814913025551: ETFPI7015SH
• 00814913025544: ETFPI6015SH
• 00814913025537: ETFPI5015SH
• 00814913025520: ETFPI4515SH
• 00814913025513: ETFPI4015SH
• 00814913025506: ETFPI4515MH
• 00814913025490: ETFPI4015MH
• 00814913025483: ETFPI7011SN
• 00814913025476: ETFPI6011SN
• 00814913025469: ETFPI5011SN
• 00814913025452: ETFPI4511SN
• 00814913025445: ETFPI4011SN
• 00814913025438: ETFPI4511MN
• 00814913025421: ETFPI4011MN
• 00814913025414: ETFPI7011SH
• 00814913025407: ETFPI6011SH
• 00814913025391: ETFPI5011SH
• 00814913025384: ETFPI4511SH
• 00814913025377: ETFPI4011SH
• 00814913025360: ETFPI4511MH
• 00814913025353: ETFPI4011MH
• 00810125994906: ETPIS6015NCA
• 00810125994890: ETPIS5015NCA
• 00810125994883: ETPIS4515NCA
• 00810125994876: ETPIS4015NCA
• 00810125994869: ETPIM4515NCA
• 00810125994852: ETPIM4015NCA
• 00810125994845: ETPIS7015CA
• 00810125994838: ETPIS6015CA
• 00810125994821: ETPIS5015CA
• 00810125994814: ETPIS4515CA
• 00810125994807: ETPIS4015CA
• 00810125994791: ETPIM4515CA
• 00810125994784: ETPIM4015CA
• 00810125994777: ETPIS7011NCA
• 00810125994760: ETPIS6011NCA
• 00810125994753: ETPIS5011NCA
• 00810125994708: ETPIS7011CA
• 00810125994913: ETPIS7015NCA
• 00810125994746: ETPIS4511NCA
• 00810125994739: ETPIS4011NCA