Identity
- Trade Name
- Blue Sky Bio, LLC FDA UDI
- Generic Name
- Dental implant analog FDA UDI
- Device Name
- Impression Coping Regular - Octagon FDA UDI
- Model / Reference
- MPOR FDA UDI
- Description
- Impression Coping Regular - Octagon FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810060222270 FDA UDI
- FDA Product Code
- EHY FDA UDI
- GMDN Term
- Dental implant analog FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6880 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
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
Category: Dental implant analog
Blue Sky Bio, LLC by Blue Sky Bio Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant analog.
- Digital Lab Analog Screw — DENTIS CO. , LTD · Class I
- DIO UF HSA INTERNAL SUB-MERGED IMPLANT SYSTEM — DIO Corporation · Class I
- One Stage TL S — I3 IMPLANT LLC · Class II
- DYNAMIC ABUTMENT® SOLUTIONS — TALLADIUM ESPAÑA SL · Class I
- ANALOG — DENTIN IMPLANTS TECHNOLOGIES LTD · Class II
- Elos Accurate® Analog for Printed Models — Elos Medtech Pinol A/S · Class I
- Implant Analog 6mm Trilobe Stainless Steel — Sterngold Dental LLC · Class I
- i-Clean SAVE Fixture Lab Analog — DENTIS CO. , LTD · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Blue Sky Bio Llc
Sources (1)
- FDA UDI 4abffb7f-82e3-44da-9a72-a28e256f4540 33 fields · synced May 31, 2026