Registered with FDA
F.M. Howell & Co.
Elmira, NY, United States. Lists 4 dental device types with FDA across 1 registered establishment.
- Device types listed
- 4
- Brands and models
- 4
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What F.M. Howell & Co. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Lister | BlueSkyBio | 2010 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Lister | BlueSkyBio | 2010 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Lister | BlueSkyBio | 2010 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Lister | BlueSkyBio | 2010 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
F.M. Howell & Co. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Blue Sky Bio, LLC (4).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 28 Mar 2008 | K073713 | BLUE SKY BIO DENTAL IMPLANT SYSTEM | Blue Sky Bio, LLC | DZE Root-Form Endosseous Implant |
| 5 May 2006 | K060957 | MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEM | Blue Sky Bio, LLC | DZE Root-Form Endosseous Implant |
| 2 Sep 2005 | K051507 | MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEM | Blue Sky Bio, LLC | DZE Root-Form Endosseous Implant |
| 10 Jun 2002 | K021833 | MODIFICATION TO BLUE SKY DENTAL IMPLANT SYSTEM | Blue Sky Bio, LLC | DZE Root-Form Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| F. M. HOWELL & CO.FDA reg. 3007366413 | Elmira, NY, United States | Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 1313700). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.