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Sign in to claim this brandCoremedtech ApS
US
Last updated May 24, 2026
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
- Address
- —
- Website
- coremedtech.dk
- —
- —
- [email protected]
- Phone
- +4522660442
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 306211589
Catalogue (71)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Dandy Scan Body | BE4, ZimVie - External Ø4.0 | FDA UDI | Class I | Active |
| Dandy Scan Body | DAL, Dentsply Sirona - ASTRA TECH Ø4.5 - 5.0 | FDA UDI | Class I | Active |
| Dandy Scan Body | DYY, Dentsply Sirona - Ankylos Ø4.5 | FDA UDI | Class I | Active |
| Dandy Scan Body | DEG, Dentsply Sirona - ASTRA TECH EV Ø3.0 | FDA UDI | Class I | Active |
| Dandy Scan Body | BCG, ZimVie - Certain Ø6.0 | FDA UDI | Class I | Active |
| Dandy Scan Body | SBX, Straumann - BLX Ø3.5-6.5 | FDA UDI | Class I | Active |
| Dandy Scan Body | BCP, ZimVie - Certain Ø3.4 | FDA UDI | Class I | Active |
| Dandy Scan Body | SBN, Straumann - Bonelevel NC Ø3.3 | FDA UDI | Class I | Active |
| Dandy Scan Body | NC5, Neodent - Cone Morse Ø5.0 | FDA UDI | Class I | Active |
| Dandy Scan Body | CCP, Camlog - Camlog Ø4.3 | FDA UDI | Class I | Active |
| Dandy Scan Body | NG5, Neodent - Grand Morse Ø5.0 | FDA UDI | Class I | Active |
| Dandy Scan Body | NG6, Neodent - Grand Morse Ø6.0 | FDA UDI | Class I | Active |
| Dandy Scan Body | DEB, Dentsply Sirona - ASTRA TECH EV Ø4.8 | FDA UDI | Class I | Active |
| Dandy Scan Body | NRW, Nobel Biocare - Replace Select WP | FDA UDI | Class I | Active |
| Dandy Scan Body | DXR, Dentsply Sirona - XiVE Ø5.5 | FDA UDI | Class I | Active |
| Dandy Scan Body | SSW, Straumann - Synocta - WN | FDA UDI | Class I | Active |
| Dandy Scan Body | NGG, Neodent - Grand Morse Ø4.0 | FDA UDI | Class I | Active |
| Dandy Scan Body | ZTP, ZimVie - TSV Ø4.5 | FDA UDI | Class I | Active |
| Dandy Scan Body | NBR, Nobel Biocare - Branemark RP | FDA UDI | Class I | Active |
| Dandy Scan Body | NAR, Nobel Biocare - Nobel Active RP | FDA UDI | Class I | Active |
| Dandy Scan Body | NCG, Neodent - Cone Morse Ø4.0 | FDA UDI | Class I | Active |
| Dandy Scan Body | DYB, Dentsply Sirona - Ankylos Ø5.5 | FDA UDI | Class I | Active |
| Dandy Scan Body | NAN, Nobel Biocare - Nobel Active NP | FDA UDI | Class I | Active |
| Dandy Scan Body | NBW, Nobel Biocare - Branemark WP | FDA UDI | Class I | Active |
| Dandy Scan Body | BCY, ZimVie - Certain Ø5.0 | FDA UDI | Class I | Active |
| Dandy Scan Body | BI3, BioHorizons - Tapered Internal Ø3.0 | FDA UDI | Class I | Active |
| Dandy Scan Body | DAS, Dentsply Sirona - ASTRA TECH Ø3.5 - 4.0 | FDA UDI | Class I | Active |
| Dandy Scan Body | CC6, Camlog - Camlog Ø6.0 | FDA UDI | Class I | Active |
| Dandy Scan Body | DEY, Dentsply Sirona - ASTRA TECH EV Ø4.2 | FDA UDI | Class I | Active |
| Dandy Scan Body | OTM, Osstem - TS - Mini | FDA UDI | Class I | Active |
| Dandy Scan Body | DE5, Dentsply Sirona - ASTRA TECH EV Ø5.4 | FDA UDI | Class I | Active |
| Dandy Scan Body | DEP, Dentsply Sirona - ASTRA TECH EV Ø3.6 | FDA UDI | Class I | Active |
| Dandy Scan Body | CCB, Camlog - Camlog Ø5.0 | FDA UDI | Class I | Active |
| Dandy Scan Body | DXG, Dentsply Sirona - XiVE Ø3.4 | FDA UDI | Class I | Active |
| Dandy Scan Body | NGU, Neodent - Grand Morse Unified Ø3.75-6.0 | FDA UDI | Class I | Active |
| Dandy Scan Body | CCY, Camlog - Camlog Ø3.8 | FDA UDI | Class I | Active |
| Dandy Scan Body | NCP, Neodent - Cone Morse Ø3.5 | FDA UDI | Class I | Active |
| Dandy Scan Body | DXY, Dentsply Sirona - XiVE Ø3.8 | FDA UDI | Class I | Active |
| Dandy Scan Body | BEY, ZimVie - External Ø5.0 | FDA UDI | Class I | Active |
| Dandy Scan Body | DYU, Dentsply Sirona - Ankylos Unified Ø3.5-7.0 | FDA UDI | Class I | Active |
| Dandy Scan Body | OTR, Osstem - TS - Regular | FDA UDI | Class I | Active |
| Dandy Scan Body | NGB, Neodent - Grand Morse Ø3.75 | FDA UDI | Class I | Active |
| Dandy Scan Body | SBR, Straumann - Bonelevel RC Ø4.1 | FDA UDI | Class I | Active |
| Dandy Scan Body | BIY, BioHorizons - Tapered Internal Ø3.5 | FDA UDI | Class I | Active |
| Dandy Scan Body | NGY, Neodent - Grand Morse Ø4.3 | FDA UDI | Class I | Active |
| Dandy Scan Body | BEB, ZimVie - External Ø3.75 | FDA UDI | Class I | Active |
| Dandy Scan Body | NBN, Nobel Biocare - Branemark NP | FDA UDI | Class I | Active |
| Dandy Scan Body | BEG, ZimVie - External Ø6.0 | FDA UDI | Class I | Active |
| Dandy Scan Body | DXB, Dentsply Sirona - XiVE Ø4.5 | FDA UDI | Class I | Active |
| Dandy Scan Body | BCB, ZimVie - Certain Ø4.1 | FDA UDI | Class I | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Coremedtech Aps Allerod Hovedstaden · DK FEI 3022806627