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Pilot Drill
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref PD-25-1.2Ref PD-31-1.1Ref PD-24-1.2Ref PD-25-1.0Ref PD-25-1.1Ref PD-24-1.1Ref PD-24-1.0Ref PD-31-0.9Ref PD-31-1.0
by DENTOS Inc.
Identity
- Trade Name
- Pilot Drill FDA UDI
- Generic Name
- Steel dental bur, reusable FDA UDI
- Device Name
- Pilot Drill EUDAMED
- Model / Reference
- PD-24-1.1 EUDAMEDFDA UDIPD-25-1.1 EUDAMEDFDA UDIPD-31-1.0 EUDAMEDFDA UDIPD-25-1.0 EUDAMEDFDA UDIPD-24-1.2 EUDAMEDFDA UDIPD-31-1.1 EUDAMEDFDA UDIPD-24-1.0 EUDAMEDFDA UDIPD-31-0.9 EUDAMEDFDA UDIPD-25-1.2 EUDAMEDFDA UDIPD-25-0.9 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806145430021 EUDAMEDFDA UDI08806145430083 EUDAMEDFDA UDI08806145430137 EUDAMEDFDA UDI08806145430076 EUDAMEDFDA UDI08806145430038 EUDAMEDFDA UDI08806145430144 EUDAMEDFDA UDI08806145430014 EUDAMEDFDA UDI08806145430120 EUDAMEDFDA UDI08806145430090 EUDAMEDFDA UDI08806145430069 FDA UDI
- Basic UDI-DI
- 88061454APD001DQ EUDAMED
- FDA Product Code
- HTW FDA UDI
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMEDL150799 ORTHODONTIC INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Steel dental bur, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Poland 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
No
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Steel dental bur, reusable
Pilot Drill by DENTOS Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- DENTOS Inc.
Sources (21)
- FDA UDI 1c9886a9-6add-4353-9368-35509653dae2 32 fields · synced Aug 1, 2026
- FDA UDI 60b3ad8c-d8e3-4a89-a67b-4fe0b0a30fa8 32 fields · synced May 29, 2026
- FDA UDI cb54419e-7b18-47f4-a4fd-713a19258508 32 fields · synced May 30, 2026
- FDA UDI cd5aaadd-c859-4a93-b0d8-ab330154fda3 32 fields · synced May 30, 2026
- FDA UDI 2224d92e-7da3-48da-8f12-42f6846fce5c 32 fields · synced May 30, 2026
- FDA UDI c6ba5ffe-5754-467b-bf47-4eee31f82224 32 fields · synced May 30, 2026
- FDA UDI d202fa6b-5386-4f76-b401-66babf0d474a 32 fields · synced May 30, 2026
- FDA UDI 51c6559e-c1d4-4af6-9819-f79f41ac7f7d 32 fields · synced May 30, 2026
- FDA UDI b2bcd110-2f3e-42ac-a21a-30a26163e18d 32 fields · synced May 30, 2026
- FDA UDI 83be9444-789b-4727-a469-259b29677415 32 fields · synced May 30, 2026
- EUDAMED d12fe8bc-abd1-4371-ab21-889918b24aff 61 fields · synced Jun 20, 2026
- EUDAMED 6354a61c-0b61-41e8-b5ad-a0eb1896602c 61 fields · synced Jul 8, 2026
- EUDAMED 77a68e25-0276-466f-8c96-7540cd237e9a 61 fields · synced Jul 9, 2026
- EUDAMED cb59fd38-653b-444d-ae2d-761e940bac76 61 fields · synced Jul 9, 2026
- EUDAMED ce637b87-976e-4973-9181-8021d77d0669 61 fields · synced Jul 10, 2026
- EUDAMED fe889380-c570-4968-8558-69f8a553a9e0 61 fields · synced Jul 14, 2026
- EUDAMED ef489a43-ad40-41c8-8ed9-212fc88a621a 61 fields · synced Jul 17, 2026
- EUDAMED c59eaaf5-93d2-46c6-9ed2-93d04e75bbfc 61 fields · synced Jul 17, 2026
- EUDAMED 3bb41492-c267-445f-bf59-764e6564e009 61 fields · synced Jul 21, 2026
- EUDAMED a7fed0cd-f524-4716-97d6-83ae61011f71 61 fields · synced Jul 28, 2026
- EUDAMED f9c97e2a-9eb5-419c-a26f-6594fd317c7b 61 fields · synced Aug 1, 2026