# Blue Sky Bio, LLC

- Location (FDA's records): Grayslake, IL
- FDA decisions: 21 (2000–2024): 21 510(k) clearances
- Names in FDA's records: Blue Sky Bio, LLC (16); Blue Sky Bio (5)
- Product codes: DZE (10), NXC (3), LYC (2), NHA (2), DYW (1), EIH (1), OAT (1), LLZ (1)
- 510(k) review time since 2016: median 190 days, against 153 for FDA's reviews in the same codes and years (4 of 9 faster)
- Predicates its devices cite: 26 (8 its own); citations of its devices by later devices: 19 (8 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Nobel Biocare AB: 1 (https://510kreport.com/company/nobel-biocare)
- Zimmer Dental, Inc.: 1 (https://510kreport.com/company/zimmer-dental)
- Institut Straumann AG: 1 (https://510kreport.com/company/institut-straumann)
- Curasan Ag, Frankfurt Facility: 1 (https://510kreport.com/company/curasan-ag-frankfurt-facility)
- Brainbase Corporation: 1 (https://510kreport.com/company/brainbase)
- Terrats Medical SL: 1 (https://510kreport.com/company/terrats-medical)
- Jjgc Industria E Comercio DE Materiais Dentarios S: 1 (https://510kreport.com/company/jjgc-industria-e-comercio-de-materiais-dentarios-s)
- Southern Implants (Pty), Ltd.: 1 (https://510kreport.com/company/southern-implants)

## Firms that cite its devices most
- Graphy, Inc.: 2 (https://510kreport.com/company/graphy)
- Cristaline Aligners GmbH: 1 (https://510kreport.com/company/cristaline-aligners)
- Surgikor, LLC: 1 (https://510kreport.com/company/surgikor)
- Jjgc Industria E Comercio DE Materiais Dentarios S.A.: 1 (https://510kreport.com/company/jjgc-industria-e-comercio-de-materiais-dentarios)
- Institut Straumann AG: 1 (https://510kreport.com/company/institut-straumann)
- Megagen Implant Co., Ltd.: 1 (https://510kreport.com/company/megagen-implant)
- Talladium España, SL: 1 (https://510kreport.com/company/talladium-espana)
- Suncoast Dental, Inc. Dba Tatum Surgical: 1 (https://510kreport.com/company/suncoast-dental-dba-tatum-surgical)

## Its most-cited devices
- K212785: Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments (2022), cited by 3
- K073713: Blue Sky Bio Dental Implant System (2008), cited by 2
- K102034: Blue Sky Bio Dental Implant System (2011), cited by 2
- K060957: Modification to Blue Sky Bio Dental Implant System (2006), cited by 2
- K202026: Blue Sky Bio CAD-CAM Abutments (2020), cited by 2
- K180107: Blue Sky Bio Aligner (2018), cited by 2

## Recent decisions
- K232653: Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX (Apr 3, 2024)
- K221845: Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G (Feb 24, 2023)
- K212785: Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments (Jun 30, 2022)
- K202026: Blue Sky Bio CAD-CAM Abutments (Dec 18, 2020)
- K201919: Blue Sky Bio TAD (Dec 17, 2020)
- K190491: Blue Sky Bio Zygomatic Implant System (Aug 12, 2019)
- K182338: Blue Sky Bio Computerized Orthodontic Bracket System (Nov 9, 2018)
- K180107: Blue Sky Bio Aligner (Feb 9, 2018)

Source page: https://510kreport.com/company/blue-sky-bio