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Reamer Tip
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref HFRTE600Ref HGSRFRT600Ref HGSRFRT500Ref HFRTE480
Identity
- Trade Name
- Reamer Tip EUDAMEDFDA UDI
- Generic Name
- Dental implant suprastructure reamer FDA UDI
- Device Name
- Surgical Instrument System EUDAMED
- Model / Reference
- HFRTE600 EUDAMEDFDA UDIHFRTE480 EUDAMEDFDA UDIHGSRFRT600 EUDAMEDFDA UDIHGSRFRT500 EUDAMEDFDA UDIFRTS480 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800209367162 EUDAMEDFDA UDI08800209367155 EUDAMEDFDA UDI08800209367735 EUDAMEDFDA UDI08800209367728 EUDAMEDFDA UDI08800209394373 FDA UDI
- Basic UDI-DI
- 88000406CLASSIBS25V EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Dental implant suprastructure reamer FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Czechia EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental implant suprastructure reamer
Reamer Tip by OSSTEM IMPLANT Co., Ltd. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Dental implant suprastructure reamer.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- OSSTEM IMPLANT Co., Ltd.
Sources (9)
- FDA UDI 88ebfb6a-1b41-4318-bc9f-cdedcd8732d9 32 fields · synced Jul 21, 2026
- FDA UDI b6bf74c3-7d20-4bde-92d7-c697f38ca27e 32 fields · synced May 29, 2026
- FDA UDI 3982d1d6-2054-465a-9dc4-369ed3b81346 32 fields · synced May 30, 2026
- FDA UDI 1f7d4e95-93f7-4466-b7ff-03e1be9d8bec 32 fields · synced May 30, 2026
- FDA UDI 46c1dbc5-1a87-4fa2-b8b1-038af01987f5 32 fields · synced May 30, 2026
- EUDAMED 882c0577-2145-41cf-b99c-93a5dc520cc2 61 fields · synced Jul 9, 2026
- EUDAMED 65e7644c-e1d5-4f6c-a025-3e4885117705 61 fields · synced Jul 15, 2026
- EUDAMED cf715b1d-2d4a-4979-a209-4fe7fb3cdbfe 61 fields · synced Jul 17, 2026
- EUDAMED 9aba4adf-39e9-4676-9268-a9c60fb27837 61 fields · synced Jul 21, 2026