Identity
- Trade Name
- Blue Sky Bio, LLC. FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- BIO | Max Base Abutment NP 4.0mm Collar FDA UDI
- Model / Reference
- ABJHNP40 FDA UDI
- Description
- BIO | Max Base Abutment NP 4.0mm Collar FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810060221310 FDA UDI
- 510(k) Number
- K202026 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental implant suprastructure, permanent, preformed FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
Yes
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Dental implant suprastructure, permanent, preformed
The Blue Sky Bio, LLC. Blue Sky Bio, LLC introduces the BIO | Max Base Abutment NP 4.0mm Collar, a prefabricated dental implant support device designed to provide a permanent intermediate fixture level between a dental implant and final prosthesis/restoration. This is an active device with ongoing updates.
Similar devices
Also classified as Dental implant suprastructure, permanent, preformed.
- SPARE CAST. SLEEVE FOR — SWEDEN & MARTINA INC · Class II
- HS/HG Prosthetic System — OSSTEM IMPLANT Co., Ltd. · Class II
- DESS dental smart solutions — TERRATS MEDICAL SL. · Class II
- Diamodent — Diamodent · Class II
- Cemented Abutment — POINTIMPLANT Co., Ltd. · Class II
- GS System — OSSTEM IMPLANT Co., Ltd. · Class II
- Temporary Abutment — Cybermed Inc. · Class II
- EZ Post — Megagen Implant Co. Ltd · Class II
Cleared under the same submission
K202026 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
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Blue Sky Bio Llc
Sources (1)
- FDA UDI 98895230-9ab8-4755-92c9-007768e0c087 34 fields · synced Aug 2, 2026