DD base P HI K50830

GUDID EDDIK508301

DD medical polymers (PMMA), made from PMMA, are industrially polymerized, pre-colored or clear dental milling blanks designed for milled fabrication of bite splints (clear variant) or denture bases (gingiva-colored variants) on dental CAD/CAM systems. DD base P HI are pre-colored dental milling blanks made of impact-resistant PMMA for the manufacture of denture bases for removable dentures. DD base P HI is suitable for longterm use in the oral cavity up to 10 years.

Dental Direkt GmbH

Dental appliance fabrication material, thermoplastic

Primary Device ID	EDDIK508301
NIH Device Record Key	4a74e630-1f31-4b4d-a79b-23b124038bae
Commercial Distribution Status	In Commercial Distribution
Brand Name	DD base P HI
Version Model Number	98H30 gingiva 3
Catalog Number	K50830
Company DUNS	313214171
Company Name	Dental Direkt GmbH
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

Customer Support Contacts

Phone	+495225863190
Email	info@dentaldirekt.de
Phone	+495225863190
Email	info@dentaldirekt.de
Phone	+495225863190
Email	info@dentaldirekt.de
Phone	+495225863190
Email	info@dentaldirekt.de
Phone	+495225863190
Email	info@dentaldirekt.de
Phone	+495225863190
Email	info@dentaldirekt.de
Phone	+495225863190
Email	info@dentaldirekt.de
Phone	+495225863190
Email	info@dentaldirekt.de
Phone	+495225863190
Email	info@dentaldirekt.de
Phone	+495225863190
Email	info@dentaldirekt.de
Phone	+495225863190
Email	info@dentaldirekt.de
Phone	+495225863190
Email	info@dentaldirekt.de
Phone	+495225863190
Email	info@dentaldirekt.de
Phone	+495225863190
Email	info@dentaldirekt.de
Phone	+495225863190
Email	info@dentaldirekt.de
Phone	+495225863190
Email	info@dentaldirekt.de
Phone	+495225863190
Email	info@dentaldirekt.de
Phone	+495225863190
Email	info@dentaldirekt.de
Phone	+495225863190
Email	info@dentaldirekt.de
Phone	+495225863190
Email	info@dentaldirekt.de
Phone	+495225863190
Email	info@dentaldirekt.de
Phone	+495225863190
Email	info@dentaldirekt.de
Phone	+495225863190
Email	info@dentaldirekt.de
Phone	+495225863190
Email	info@dentaldirekt.de
Phone	+495225863190
Email	info@dentaldirekt.de
Phone	+495225863190
Email	info@dentaldirekt.de
Phone	+495225863190
Email	info@dentaldirekt.de
Phone	+495225863190
Email	info@dentaldirekt.de
Phone	+495225863190
Email	info@dentaldirekt.de

Device Dimensions

Height	30 Millimeter
Outer Diameter	98.5 Millimeter
Height	30 Millimeter
Outer Diameter	98.5 Millimeter
Height	30 Millimeter
Outer Diameter	98.5 Millimeter
Height	30 Millimeter
Outer Diameter	98.5 Millimeter
Height	30 Millimeter
Outer Diameter	98.5 Millimeter
Height	30 Millimeter
Outer Diameter	98.5 Millimeter
Height	30 Millimeter
Outer Diameter	98.5 Millimeter
Height	30 Millimeter
Outer Diameter	98.5 Millimeter
Height	30 Millimeter
Outer Diameter	98.5 Millimeter
Height	30 Millimeter
Outer Diameter	98.5 Millimeter
Height	30 Millimeter
Outer Diameter	98.5 Millimeter
Height	30 Millimeter
Outer Diameter	98.5 Millimeter
Height	30 Millimeter
Outer Diameter	98.5 Millimeter
Height	30 Millimeter
Outer Diameter	98.5 Millimeter
Height	30 Millimeter
Outer Diameter	98.5 Millimeter
Height	30 Millimeter
Outer Diameter	98.5 Millimeter
Height	30 Millimeter
Outer Diameter	98.5 Millimeter
Height	30 Millimeter
Outer Diameter	98.5 Millimeter
Height	30 Millimeter
Outer Diameter	98.5 Millimeter
Height	30 Millimeter
Outer Diameter	98.5 Millimeter
Height	30 Millimeter
Outer Diameter	98.5 Millimeter
Height	30 Millimeter
Outer Diameter	98.5 Millimeter
Height	30 Millimeter
Outer Diameter	98.5 Millimeter
Height	30 Millimeter
Outer Diameter	98.5 Millimeter
Height	30 Millimeter
Outer Diameter	98.5 Millimeter
Height	30 Millimeter
Outer Diameter	98.5 Millimeter
Height	30 Millimeter
Outer Diameter	98.5 Millimeter
Height	30 Millimeter
Outer Diameter	98.5 Millimeter
Height	30 Millimeter
Outer Diameter	98.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EDDIK508301 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K230410

FDA Product Code

EBI	Resin, Denture, Relining, Repairing, Rebasing

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	2023-08-04
Device Publish Date	2023-07-27

On-Brand Devices [DD base P HI]

EDDIK503301	DD medical polymers (PMMA), made from PMMA, are industrially polymerized, pre-colored or clear d
EDDIK503251	DD medical polymers (PMMA), made from PMMA, are industrially polymerized, pre-colored or clear d
EDDIK503201	DD medical polymers (PMMA), made from PMMA, are industrially polymerized, pre-colored or clear d
EDDIK502301	DD medical polymers (PMMA), made from PMMA, are industrially polymerized, pre-colored or clear d
EDDIK502251	DD medical polymers (PMMA), made from PMMA, are industrially polymerized, pre-colored or clear d
EDDIK502201	DD medical polymers (PMMA), made from PMMA, are industrially polymerized, pre-colored or clear d
EDDIK501301	DD medical polymers (PMMA), made from PMMA, are industrially polymerized, pre-colored or clear d
EDDIK501251	DD medical polymers (PMMA), made from PMMA, are industrially polymerized, pre-colored or clear d
EDDIK501201	DD medical polymers (PMMA), made from PMMA, are industrially polymerized, pre-colored or clear d
EDDIK508301	DD medical polymers (PMMA), made from PMMA, are industrially polymerized, pre-colored or clear d
EDDIK507301	DD medical polymers (PMMA), made from PMMA, are industrially polymerized, pre-colored or clear d
EDDIK506301	DD medical polymers (PMMA), made from PMMA, are industrially polymerized, pre-colored or clear d

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