FDA Registration
Active
🇺🇸 United States
Keystone Dental Inc.
Reg #: 3011936113
·
FEI: 3011936113
·
Expires 2026
Products
12
Proprietary Names
91
Establishment Types
3
Classifications
12
Registration Details
- Registration Name
- Keystone Dental Inc.
- Registration Number
- 3011936113
- FEI Number
- 3011936113
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 13645 Alton Pkwy Ste A
- City
- Irvine
- State
- CA
- ZIP
- 92618
- Country
- US
Regulatory Submissions
- 510(k) Number
- K994205
Owner / Operator
- Firm Name
- Keystone Dental Inc.
- Operator Number
- 9096980
- Address
- 13645 Alton Pkwy Ste A
- City
- Irvine
- State
- CA
- Postal Code
- 92618
- Country
- US
- Correspondent
- Brian Lanza
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2009-01-13 |
| Bone Grafting Material, Human Source | NUN | Class 2 | Dental | No | 2007-02-27 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2008-10-07 |
| Dental Implant Surgical Tray | OFY | Class 1 | Dental | No | 2013-01-15 |
| Bone Grafting Material, Synthetic | LYC | Class 2 | Dental | No | 2009-01-13 |
| Drill, Dental, Intraoral | DZA | Class 1 | Dental | No | 2010-10-25 |
| Bur, Dental | EJL | Class 1 | Dental | No | 2010-10-25 |
| Handle, Instrument, Dental | EJB | Class 1 | Dental | No | 2010-10-25 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2007-01-23 |
| Gauge, Depth, Instrument, Dental | EIL | Class 1 | Dental | No | 2010-10-25 |
| Teeth, Porcelain | ELL | Class 2 | Dental | No | 2009-01-13 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2010-10-25 |
Proprietary Names
Modification of RD Single
ORTHOBLAST II PASTE
PUTTY
Stage-One Single Stage RBM
Restore Hex Cylinder DIS
Endosseous Dental Implant System
HA & TPS Restore Self-Tapping Syste
PrimaConnex Dental Implant System
MAX-TL Dental Implant System
Accell Connexus
OCT Dental Implant System
Single Tooth Abutment System
Tri-Nex Co Axis
Prima Dental Implant System
STAGE-1 Dental Implant System
RENOVA Dental Implant System
RESTORE Dental Implant System
Genesis Implant System
Restore HA Dental Implant System
Calmatrix Calcium Sulfate Bone Graf
Zygomatic
Stage-One Temporary Healing Cap
Initial Drill for Renova Implants
Intermediate Drill for Renova Implants
Twist Drill for Renova Implants
Surgical Tap for Renova Implants
Countersink Drill for 3.75 Hex Implants
Pilot Drill for Renova Implants
Finishing Drill for Renova Implants
Surgical Tap for External Hex Threaded Implants
Pilot Drill for Restore Implants
Tri-Spade Drill for Cylinder Implants
Countersink Drill for Prima Implants
Surgical Tap for Genesis Implants
Twist Drill for Stage-1 Single Stage Implant System
Tapered Drill for Genesis Implants
Tapered Drill for Prima Implants
Surgical Countersink Dril for Stage-1 Implants
Tapered Drill for Renova Implants
Bone Profiler with Centering Pin for PrimaConnex Implants
Twist Drill for External Hex Threaded Implants
Surgical Tap for Stage-1 Single Stage Implant System
Tissue Punch and Guide for Prima Implants
Full Depth Twist Drill for Genesis Implants
Straight Drill for Genesis Implants
Countersink Drill for Renova Implants
Intermediate Drill for Genesis Implants
Initial Drill for Prima Implants
Straight Drill for Prima Implants
Bone Profiler w/Guide Pin for External Hex Implants
Step Drill for Prima Implants
Initial Drill for Genesis Implants
Surgical Tap for Prima Implants
Calforma Calcium Sulfate Bone Graft
UCLA CoCr Sleeve, SD For PrimaConne
RD, UCLA CoCr Sleeve for Hex Implan
UCLA CoCr Sleeve, RD For PrimaConne
Arcitexture Surface Technology
O-Ring Abutment
Sustain Hex HA Cylinder DIS
Restore Self-Tapping Dental Implant
Restore Self-Tapping Implant System
RBM Self-Tapping Threaded Implant WD External Hex Prosthetic Connection 6 x 6.5mm
PrimaConnex Esthetic Contour Zi Abutments
Restore Self-Tapping DIS
RD Single Stage TPS
Genesis ACTIVE
HA & TPS Restore Self-tapping Impla
Tri-Nex Dental Implant System
Co-Axis Implant
Co Axis
DynaGraft
HA-Biontegrated DIS
XP1 Dental Implant System
NSI Hexed and Non-Hexed Implant System
Stage-One Angled Abutment System
Radiographic Depth Gauge for Genesis Implant System
Depth Probe for Prima Implant Systems
Surgical Depth Probe for External Hex Threaded Implants (Restore)
Surgical Depth Gauge for Renova Implant System
Surgical Depth Gauge for Stage-1 Single Stage Implant System
PrimaSolo One-Piece Tapered Implants
PrimaSoloTemporary/Healing Caps
PrimaSolo Dental Implant System
Restore TPS Dental Implant System
TiLobe Multi-Unit Abutments
PrimaConnex Cad/Cam Abutment System
Genesis Dental Implant System
Restore TPS Hex Cylinder Implants
NSI Hex Non-Hex Parallel
Prima Plus Conical
Establishment Types
Manufacture Medical Device
Manufacture Device in the United States for Export Only
Complaint File Establishment per 21 CFR 820.198