FDA Registration
Active
🇺🇸 United States
IMPLANT DIRECT SYBRON MANUFACTURING LLC
Reg #: 3001617766
·
FEI: 3001617766
·
Expires 2026
Products
8
Proprietary Names
31
Establishment Types
2
Classifications
8
Registration Details
- Registration Name
- IMPLANT DIRECT SYBRON MANUFACTURING LLC
- Registration Number
- 3001617766
- FEI Number
- 3001617766
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 3050 East Hillcrest Drive
- City
- Thousand Oaks
- State
- CA
- ZIP
- 91362
- Country
- US
Regulatory Submissions
- 510(k) Number
- K130572
Owner / Operator
- Firm Name
- Implant Direct
- Operator Number
- 9069060
- Address
- 3050 East Hillcrest Drive, --
- City
- Thousand Oaks
- State
- CA
- Postal Code
- 91362
- Country
- US
- Correspondent
- Laura Caltagirone
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2014-02-28 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2014-02-28 |
| Dental Abutment Design Software For Dental Laboratory | PNP | Class 2 | Dental | No | 2019-11-06 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2021-02-23 |
| Bur, Dental | EJL | Class 1 | Dental | No | 2018-02-21 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2015-07-13 |
| Drill, Bone, Powered | DZI | Class 2 | Dental | No | 2023-08-28 |
| Attachment, Precision, All | EGG | Class 1 | Dental | No | 2025-09-09 |
Proprietary Names
InterActive/SwishPlus2 Implant System
K061319
Spectra System: Legacy, RePlant, Simply Replant, ScrewIndirect
Simply Legacy 3, Legacy3 6mm Length Implant System
Spectra-System Abutments 2008: Legacy, RePlant, ScrewPlus, ScrewPlant, ScrewIndirect
Legacy SMARTbase Abutments
Standard Sterilizable Tray
Custom Legacy and Custom InterActive Titanium Abutments
Chairside bur block
InterActive SMARTBase Abutments
SIMPLY ICONIC Implants
SwishPlant Dental Implant System
Mini Sterilizable Tray
Drill Stop Kit - Long Empty, Drill Stop Kit - Short Empty
Implant Direct: Tooling, Hex Driver
OEM: Stainless Steel Ratchet, 30Ncm Torque Wrench, Torque Wrench Multi-Setting, Stainless Steel Handle - Multiple
Guided Surgery Kit
K060063
Legacy Abutment System
K080713
ReActive Dental Implant System
K090234
Legacy, GoDirect, RePlant, Simply Replant, ScrewIndirect
K080633
ScrewIndirect Dental Implants
Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts
InterActive Complete Surgical Tray
Surgical Drills
Ball Abutment Housing, Ball Abutment Nylon Liner, Ball Abutment Housing & Liner
SMARTbase Abutment System
Simply InterActive
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device