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EUDAMED last updated this device on Jul 1, 2026
697628156DB3EDiamond burs is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by FuQuan Toboom Technologies Co., Ltd. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06976281560011TBR-48F(01)06976281560011
European Medical Device Nomenclature — the EU product classification assigned to this device.
L159007ODONTOSTOMATOLOGY BURS, REUSABLE1 warning recorded — scroll inside the panel to see all entries.
Don’t use in patients with a known nickel allergy.The metal components (e.g., substrate or bonding matrix) of the instrument may contain nickel, which could trigger an allergic reaction upon contact with tissues. Potential Consequence: May lead to local or systemic allergic reactions, including but not limited to contact dermatitis, skin rash, redness and swelling, or more severe systemic symptoms. Precautionary Measure: Prior to use, the dentist must actively inquire if the patient has a known history of metal allergy (especially to nickel). For such patients, avoid use or implement extreme isolation measures and closely monitor for any adverse reactions.
CN-MF-000046959No certificate specifically references this device's Basic UDI-DI.
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Primary placement in Germany; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Jul 10, 2026 | Dec 31, 2029 |
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
View in glossary →Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
View in glossary →Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
View in glossary →CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
View in glossary →Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →MDR risk classes
MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Certificate health across this manufacturer's portfolio.
HZ 2286953-1IssuedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.