FDA Registration
Active
🇺🇸 United States
IMPLADENT, LTD.
Reg #: 2431866
·
FEI: 2431866
·
Expires 2026
Products
5
Proprietary Names
4
Establishment Types
3
Classifications
5
Registration Details
- Registration Name
- IMPLADENT, LTD.
- Registration Number
- 2431866
- FEI Number
- 2431866
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 30 Bearfoot Rd
- City
- Northborough
- State
- MA
- ZIP
- 01532
- Country
- US
Regulatory Submissions
- 510(k) Number
- K090794
Owner / Operator
- Firm Name
- IMPLADENT, LTD.
- Operator Number
- 2431866
- Address
- 30 Bearfoot Rd
- City
- Northborough
- State
- MA
- Postal Code
- 01532
- Country
- US
- Correspondent
- Zachary - Adler
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bone Grafting Material, Animal Source | NPM | Class 2 | Dental | No | 2011-09-22 |
| Wound Dressing With Animal-Derived Material(S) | KGN | Class U | Unknown | No | 2013-07-11 |
| Bone Grafting Material, Synthetic | LYC | Class 2 | Dental | No | 2007-12-28 |
| Plate, Bone | JEY | Class 2 | Dental | No | 2015-10-26 |
| Screw, Fixation, Intraosseous | DZL | Class 2 | Dental | No | 2015-10-26 |
Proprietary Names
OsteoTape / OsteoGen Plug / OsteoGen Strip
CollaForm / OsteoMend XTD
OsteoGen
TriStar Bone Graft Fixation System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device
Manufacture Medical Device