Burn-out Cylinder
by Dentium Co., Ltd. 2 variants
Ref GSBC43
Burn-out Cylinder (GSBC43) is a Class I device made by Dentium Co., Ltd., registered in EUDAMED on 2 Nov 2026 (Basic UDI-DI 880969136DENTIUM007QD), active as of 7 Nov 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number880969136DENTIUM007QD 08809544906821 | Date2 Nov 2026 | StatusActive |
Official records
- EUDAMED public site 880969136DENTIUM007QD
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- Laboratory instruments
- Model / reference
- GSBC43
- Primary DI / UDI-DI
- 08809544906821
- Basic UDI-DI
- 880969136DENTIUM007QD
- EMDN code
- Q010207 Dental impression devices for prosthetic dentistry
- Device class
- Class I
- EU registration type
- Standard device
- EU market of registration
- Hungary
Manufacturer details
- EUDAMED SRN
- KR-MF-000023279
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Similar devices in this category
Other devices filed under DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY.
- Impression tray with edge rotable solid 3021336 by LIPUMA
- Abiding Solo Plastic Coping ASPCS-45 by SNUCONE Co., LTD.
- UNP CloseFit™ Close Tray Transfer Screw Short UNP5126 by ADIN DENTAL IMPLANT SYSTEMS LTD.
- UniFit Open Tray Transfer Screw Short UF5010 by ADIN DENTAL IMPLANT SYSTEMS LTD.
- Impression tray with edge U3 solid (upper) size M 3021315 by LIPUMA
- LW Oss Abutment Scan Body LWOSB458HS by Ossvis Co., Ltd.
- LW Oss Abutment Pick-up Impression Coping LWOPI45HS by Ossvis Co., Ltd.