Question 1

What types of medical devices does Coremedtech ApS manufacture?

Accepted Answer

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.

Question 2

Where is Coremedtech ApS based?

Accepted Answer

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.

Question 3

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

Accepted Answer

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.

Question 4

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

Accepted Answer

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.

Device	Model / Reference	Registries	Class	Status
Dandy Scan Body	NRN, Nobel Biocare - Replace Select NP	FDA UDI	Class I	Active
Dandy Scan Body	NCB, Neodent - Cone Morse Ø3.75	FDA UDI	Class I	Active
Dandy Scan Body	BIG, BioHorizons - Tapered Internal Ø4.5	FDA UDI	Class I	Active
Dandy Scan Body	NRR, Nobel Biocare - Replace Select RP	FDA UDI	Class I	Active
Dandy Scan Body	NA3, Nobel Biocare - Nobel Active Ø3.0	FDA UDI	Class I	Active
Dandy Scan Body	DYR, Dentsply Sirona - Ankylos Ø3.5	FDA UDI	Class I	Active
Dandy Scan Body	SSR, Straumann - Synocta - RN	FDA UDI	Class I	Active
Dandy Scan Body	BEP, ZimVie - External Ø3.25	FDA UDI	Class I	Active
Dandy Scan Body	BIB, BioHorizons - Tapered Internal Ø5.7	FDA UDI	Class I	Active
Dandy Scan Body	NCU, Neodent - Cone Morse Unified Ø3.75-5.0	FDA UDI	Class I	Active
Dandy Scan Body	DX3, Dentsply Sirona - XiVE Ø3.0	FDA UDI	Class I	Active
Dandy Scan Body	NGP, Neodent - Grand Morse Ø3.5	FDA UDI	Class I	Active
Dandy Scan Body	NAW, Nobel Biocare - Nobel Active WP	FDA UDI	Class I	Active
Dandy Scan Body	DAX, Dentsply Sirona - ASTRA TECH Ø3.0	FDA UDI	Class I	Active
Dandy Scan Body	CCG, Camlog - Camlog Ø3.3	FDA UDI	Class I	Active
Dandy Scan Body	ZTG, ZimVie - TSV Ø3.5	FDA UDI	Class I	Active
Dandy Scan Body	NCY, Neodent - Cone Morse Ø4.3	FDA UDI	Class I	Active
Dandy Scan Body	DYG, Dentsply Sirona - Ankylos Ø7.0	FDA UDI	Class I	Active
Dandy Scan Body	NR6, Nobel Biocare - Replace Select Ø6.0	FDA UDI	Class I	Active
Dandy Scan Body	ZTY, ZimVie - TSV Ø5.7	FDA UDI	Class I	Active
Dandy Scan Body	SSN, Straumann - Synocta - NNC	FDA UDI	Class I	Active

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