AS 260 Handpiece
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- AS 260 Handpiece EUDAMEDNeoScan™ 2000 Handpiece EUDAMEDOwandy ios Handpiece EUDAMEDST 200E Handpiece EUDAMEDNeoss FDA UDIStraumann Sirios FDA UDI
- Generic Name
- Intraoral optical scanning system FDA UDI
- Device Name
- Intraoral Scanner EUDAMED
- Model / Reference
- AS 100, AS 200E, AS 260, AS 260a, S300W, ST 200E, ST 300E, NeoScan 1000, NeoScan 2000, Owandy ios, Owandy ios Wireless, DI-1 EUDAMED6583243 EUDAMED91041 EUDAMED6583362 EUDAMEDST6583217 EUDAMEDNeoScan 2000-Handpiece FDA UDIST 200E Handpiece FDA UDI
Identifiers
- Catalog Number
- 91041 FDA UDI
- Primary DI / UDI-DI
- 06973993440808 EUDAMED06973993440099 EUDAMEDFDA UDI06973993440204 EUDAMEDFDA UDI06973993440129 EUDAMED
- Basic UDI-DI
- 697399344alliedstar01SL EUDAMED
- Direct Marketing DI
- 06973993440099 EUDAMED06973993440129 EUDAMED06973993440204 EUDAMED
- FDA Product Code
- NOF FDA UDI
- EMDN Code
- Q010207 DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY EUDAMED
- GMDN Term
- Intraoral optical scanning system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3661 FDA UDI
- Market of Registration
- Hungary EUDAMEDItaly EUDAMEDFrance EUDAMEDGermany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: Dental implant suprastructure, temporary, preformed, single-use
AS 260 Handpiece by Alliedstar Medical Equipment Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, temporary, preformed, single-use.
- Intraoral Scanbody — ARUM DENTISTRY Co., Ltd. · Class I
- Impression Coping — ARUM DENTISTRY Co., Ltd. · Class I
- Intraoral Scanbody — ARUM DENTISTRY Co., Ltd. · Class I
- Retaining Screw for Digital Model Analog — ADIN DENTAL IMPLANT SYSTEMS LTD. · Class I
- Falcon — Falcon Surgical Co. (Pvt.) Ltd · Class I
- Impression Coping — ARUM DENTISTRY Co., Ltd. · Class I
- Neoss Implant System — Neoss, Ltd. · Class II
- Scanbody Screw — ARUM DENTISTRY Co., Ltd. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697399344alliedstar01SL | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Alliedstar Medical Equipment Co., Ltd.
- EUDAMED SRN
- CN-MF-000008845
- Authorised Representative
- Etkon GmbH DE-AR-000009335
Sources (6)
- EUDAMED ac647265-7261-4b93-bd5d-8c7f4b6d2514 61 fields · synced Aug 3, 2026
- FDA UDI be13d304-c81c-4ba0-ba4a-f426fdc44591 33 fields · synced May 30, 2026
- FDA UDI c03bac0b-a385-4992-adcc-de2c3ca86e15 32 fields · synced May 30, 2026
- EUDAMED bd6f1ced-db65-4cd0-a492-b0811410c2e2 61 fields · synced Jul 11, 2026
- EUDAMED ba6b7892-ba3a-4a76-b0b6-e9bcd28aaa50 61 fields · synced Jul 11, 2026
- EUDAMED 2089d1db-757c-4626-8d4a-47c0408cdee8 61 fields · synced Aug 3, 2026