Skip to content

Coremedtech ApS

US Last updated 24 May 2026

Devices
71
Registries
GUDIDFDA
FDA recalls
0

Catalogue71

Page 1 of 2

Showing 1-50 of 71

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Coremedtech Aps Allerod Hovedstaden · DK FEI 3022806627

What Coremedtech ApS makes

Coremedtech ApS manufactures single-use dental implant abutment analogs designed specifically for intraoral scanning. These devices are intended to replicate the shape and dimensions of dental implant abutments, enabling precise digital impressions for restorative planning in dentistry.

The company’s products fall under FDA Class I medical devices and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Coremedtech ApS manufacture?

Coremedtech ApS specializes in dental implant abutment analogs that are designed for single-use intraoral scanning. These devices replicate the shape and dimensions of dental implant abutments to create accurate digital impressions, which are critical for planning restorative dental procedures. The focus is on enabling precise digital workflows in dentistry.

Where is Coremedtech ApS based?

Coremedtech ApS is based in the United States. The company’s location influences its regulatory compliance and reporting requirements, particularly for devices marketed in the US.

Which regulatory registries or databases list Coremedtech ApS’s devices?

Coremedtech ApS’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for dental implant abutment analogs, helping healthcare providers and regulators identify and verify the devices.

How are Coremedtech ApS’s devices classified under medical device regulations?

Coremedtech ApS’s dental implant abutment analogs fall under FDA Class I medical devices. This classification is typically assigned to low-risk devices where general controls (like good manufacturing practices) are sufficient to ensure safety and effectiveness. The classification reflects the minimal risk associated with single-use scanning analogs.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
Phone
+4522660442
DUNS number
306211589