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Drills and Handpieces
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref CH-D-CMRef I-H-PRO12D-GSRef D-414TRef D-ZYG-RBRef D-ZYG-CH-27Ref D-ZYG-CH-29Ref I-BPM-40Ref D-ZYG-CH-29SRef D-ZYG-29SRef I-CON-X
Identity
- Trade Name
- N/A FDA UDINA FDA UDI
- Generic Name
- Fixture/appliance dental drill bit, reusable FDA UDIDental implant holding endpiece, reusable FDA UDIFixture/appliance dental drill bit, single-use FDA UDI
- Device Name
- Drills and Handpieces EUDAMEDInstrument, Side-cut Burr, Ø2.8 - Ø3.9mm, Ti FDA UDITapered Drill for Ø4.0 ITT, Ø4.1 x 14.5mm FDA UDIInstrument, Connector to Handpiece FDA UDIMulti-Use Twist Drill for Zygomatic, Ø2.7mm, Stainless Steel FDA UDIMulti-Use Twist Drill for Zygomatic, Short, Ø2.9mm, Stainless Steel FDA UDIMulti-Use Twist Drill for Zygomatic, Ø2.9mm, Stainless Steel FDA UDIRound Burr for Zygomatic, Ø2.9mm FDA UDITwist Drill for Zygomatic, Short, Ø2.9mm FDA UDI
- Model / Reference
- CH-D-CM EUDAMEDFDA UDII-H-PRO12D-GS EUDAMEDD-414T EUDAMEDFDA UDID-ZYG-RB EUDAMEDFDA UDID-ZYG-CH-27 EUDAMEDFDA UDID-ZYG-CH-29 EUDAMEDFDA UDII-BPM-40 EUDAMEDD-ZYG-CH-29S EUDAMEDFDA UDID-ZYG-29S EUDAMEDFDA UDII-CON-X EUDAMEDFDA UDI
- Description
- Instrument, Side-cut Burr, Ø2.8 - Ø3.9mm, Ti FDA UDITapered Drill for Ø4.0 ITT, Ø4.1 x 14.5mm FDA UDIInstrument, Connector to Handpiece FDA UDIMulti-Use Twist Drill for Zygomatic, Ø2.7mm, Stainless Steel FDA UDIMulti-Use Twist Drill for Zygomatic, Short, Ø2.9mm, Stainless Steel FDA UDIMulti-Use Twist Drill for Zygomatic, Ø2.9mm, Stainless Steel FDA UDIRound Burr for Zygomatic, Ø2.9mm FDA UDITwist Drill for Zygomatic, Short, Ø2.9mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06009544035008 EUDAMEDFDA UDI06009544038283 EUDAMED06009544003557 EUDAMEDFDA UDI06009544006732 EUDAMEDFDA UDI06009544039945 EUDAMEDFDA UDI06009544036661 EUDAMEDFDA UDI06009544035596 EUDAMED06009544036678 EUDAMEDFDA UDI06009544006688 EUDAMEDFDA UDI06009544010586 EUDAMEDFDA UDI
- Basic UDI-DI
- 6009544038759C EUDAMED
- Direct Marketing DI
- 06009544035008 EUDAMED06009544038283 EUDAMED06009544003557 EUDAMED06009544006732 EUDAMED06009544039945 EUDAMED06009544036661 EUDAMED06009544035596 EUDAMED06009544036678 EUDAMED06009544006688 EUDAMED06009544010586 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMEDL99 SURGICAL INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Fixture/appliance dental drill bit, reusable FDA UDIDental implant holding endpiece, reusable FDA UDIFixture/appliance dental drill bit, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Portugal EUDAMEDGermany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDIEUDAMEDFDA UDI
Single Use
Yes
FDA UDIFDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Drills and Handpieces by Southern Implants (pty) Ltd — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6009544038759C | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Southern Implants (Pty) Ltd
- EUDAMED SRN
- ZA-MF-000035362
- Authorised Representative
- Southern Implants Europe AB SE-AR-000032508
Sources (25)
- EUDAMED bc65c659-f165-4fde-add8-a0be3df2db0d 61 fields · synced Jul 29, 2026
- EUDAMED f51fd894-2cc3-480a-b415-1e878333e524 61 fields · synced May 17, 2026
- EUDAMED ae62847a-df2d-438c-8e81-2179e25d8c9d 61 fields · synced May 17, 2026
- EUDAMED d201da34-d51d-4346-910d-bc98e79382dc 61 fields · synced May 18, 2026
- EUDAMED 4618b5d5-2ed3-4c6c-8616-6b830bc0eb33 61 fields · synced May 18, 2026
- EUDAMED 813810fb-4e4a-4c94-b211-149dbc2803fb 61 fields · synced May 18, 2026
- EUDAMED 051724a4-4ff2-437e-8aa7-94f1700c8891 61 fields · synced May 18, 2026
- EUDAMED 417940d4-8930-4906-b4db-6e0572cfe7a7 61 fields · synced May 18, 2026
- EUDAMED 0bb598b5-fd16-4fc7-bb9f-4f3dd4f96878 61 fields · synced May 19, 2026
- EUDAMED 37c8d3cd-f2d6-4f7a-8289-5b836bd9f3e4 61 fields · synced May 19, 2026
- FDA UDI eb6fdf8b-d36d-483f-8f0c-2841858f38d4 33 fields · synced May 29, 2026
- FDA UDI 601fba7e-fe6e-423d-b54b-462abd354fea 33 fields · synced May 30, 2026
- FDA UDI 0576654e-6f37-45eb-89f7-5135708485ac 33 fields · synced May 30, 2026
- FDA UDI f8760092-add0-4b66-af4e-189658a74fa8 33 fields · synced May 30, 2026
- FDA UDI cf0a8573-a9fc-4414-b1bd-e9c64caf0101 33 fields · synced May 30, 2026
- FDA UDI f4983a7d-cb3d-45b1-9b55-837c3a97d70b 33 fields · synced May 30, 2026
- FDA UDI fc36b09e-f670-41bf-98cb-9d3da60bbd70 33 fields · synced May 30, 2026
- FDA UDI b8669bcf-8d22-4c54-b2b5-4dcbc3a4ffc2 33 fields · synced May 30, 2026
- EUDAMED 43f2f5f1-87ff-4217-a35e-9ef47f97b43c 61 fields · synced Jun 20, 2026
- EUDAMED 945efc23-8e69-4db9-924b-66f97f7dabd9 61 fields · synced Jul 9, 2026
- EUDAMED 7526b108-14cc-4236-9b37-f6c5ca90f669 61 fields · synced Jul 10, 2026
- EUDAMED e99db24a-db39-44e2-8010-fe6711db213d 61 fields · synced Jul 11, 2026
- EUDAMED b8146447-f7a5-4362-846f-b773633cb76e 61 fields · synced Jul 11, 2026
- EUDAMED eab09f6b-5485-4cd9-b7f1-89957f69ed79 61 fields · synced Jul 13, 2026
- EUDAMED 9136e034-910e-4ffa-84f6-a875f771fe71 61 fields · synced Jul 16, 2026