Identity
- Trade Name
- BlueSkiBio FDA UDI
- Generic Name
- Dental surgical power tool motorized handpiece/set, electric FDA UDI
- Device Name
- The AEU-1000BSB-70V dental Implant Motor System with variable-speed footswitch Blue Sky Bio is a drive system for instruments and tools used in dentistry for implant procedures. FDA UDI
- Model / Reference
- AEU-1000BSB-70V FDA UDI
- Description
- The AEU-1000BSB-70V dental Implant Motor System with variable-speed footswitch Blue Sky Bio is a drive system for instruments and tools used in dentistry for implant procedures. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10817417020753 FDA UDI
- FDA Product Code
- EKX FDA UDI
- GMDN Term
- Dental surgical power tool motorized handpiece/set, electric FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4200 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental surgical power tool motorized handpiece/set, electric
BlueSkiBio by Aseptico, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental surgical power tool motorized handpiece/set, electric.
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- MAXSO — Beyes Dental Canada Inc · Class I
- Brasseler USA — Peter Brasseler Holdings, LLC · Class I
- Medidenta — Medidenta · Class I
- StarDental — DENTALEZ, INC. · Class I
- StarDental Instrument Solutions — DENTALEZ, INC. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Aseptico, Inc.
Sources (1)
- FDA UDI 145b821b-49ab-42cd-bbae-5ad177a9760b 35 fields · synced May 31, 2026