CERALOG PL Implant, Ø 5.0 L 13 HP1040.5013

GUDID 07640161396500

Dental Implant

Dentalpoint AG

Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system

Primary Device ID	07640161396500
NIH Device Record Key	df7511be-87a9-4dcd-9991-52abf96b9d52
Commercial Distribution Status	In Commercial Distribution
Brand Name	CERALOG PL Implant, Ø 5.0 L 13
Version Model Number	HP1040.5013
Catalog Number	HP1040.5013
Company DUNS	483229493
Company Name	Dentalpoint AG
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	false
Manufacturing Date	true
Expiration Date	true
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	07640161396500 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K163043

FDA Product Code

DZE	Implant, Endosseous, Root-Form

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2024-05-07
Device Publish Date	2024-04-29

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