Identity
- Trade Name
- Blue Sky Bio, LLC FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- BIO | Max Implant WT 3.7 x 8mm FDA UDI
- Model / Reference
- IJHWT3708 FDA UDI
- Description
- BIO | Max Implant WT 3.7 x 8mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810060220719 FDA UDI
- 510(k) Number
- K102034 FDA UDI
- FDA Product Code
- DZE FDA UDI
- GMDN Term
- Dental implant suprastructure, permanent, preformed FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental implant suprastructure, permanent, preformed
Blue Sky Bio, LLC by Blue Sky Bio Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K102034 also covers:
- Blue Sky Bio, LLC — BLUE SKY BIO LLC
- Blue Sky Bio, LLC — BLUE SKY BIO LLC
- Blue Sky Bio, LLC — BLUE SKY BIO LLC
- Blue Sky Bio, LLC — BLUE SKY BIO LLC
- Blue Sky Bio, LLC — BLUE SKY BIO LLC
- Blue Sky Bio, LLC — BLUE SKY BIO LLC
- Blue Sky Bio, LLC — BLUE SKY BIO LLC
- Blue Sky Bio, LLC — BLUE SKY BIO LLC
- Blue Sky Bio, LLC — BLUE SKY BIO LLC
- Blue Sky Bio, LLC — BLUE SKY BIO LLC
- Blue Sky Bio, LLC — BLUE SKY BIO LLC
- Blue Sky Bio, LLC — BLUE SKY BIO LLC
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 II | Pending data |
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Manufacturer
- Manufacturer
- Blue Sky Bio Llc
Sources (1)
- FDA UDI 637102a9-a59c-41ab-b9a2-8bf96aefb4f2 34 fields · synced Jun 1, 2026