Identity
- Trade Name
- SCALER 11-12S (3/8) BLACK EUDAMEDAmerican Eagle Instruments FDA UDI
- Generic Name
- Manual dental scaler, reusable FDA UDI
- Device Name
- Manual Dental Scaler, Reusable EUDAMEDSCALER 11-12S (3/8) BLACK FDA UDI
- Model / Reference
- AES11-12SX EUDAMEDFDA UDI
- Description
- SCALER 11-12S (3/8) BLACK FDA UDI
Identifiers
- Catalog Number
- AES11-12SX FDA UDI
- Primary DI / UDI-DI
- 00841013110573 EUDAMEDFDA UDI
- Basic UDI-DI
- 0841013135320EMND1696817Q EUDAMED
- FDA Product Code
- EMN FDA UDI
- EMDN Code
- Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Manual dental scaler, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Finland 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Scaler 11-12s (3/8) Black by American Eagle Instruments — Class I — 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 | 0841013135320EMND1696817Q | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- American Eagle Instruments
- EUDAMED SRN
- US-MF-000018222
- Authorised Representative
- Young Microbrush Ireland Ltd IE-AR-000011249
Sources (2)
- EUDAMED 99e3e151-13a1-4735-b722-9f01402443e0 61 fields · synced Jun 17, 2026
- FDA UDI 516e35cd-0c9d-4168-9806-5142292ad180 35 fields · synced May 30, 2026