Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011936113

FEI Number

3011936113

Entity Name

Keystone Dental Inc.

City/State/Country

Irvine, CA, US

Establishment Address

13645 Alton Pkwy Ste A, Irvine, CA 92618, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Keystone Dental Inc. (Owner Number: 9096980)

Owner / Operator Contact Address

13645 Alton Pkwy Ste A, Irvine, CA 92618, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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 MAX-TL Dental Implant System Restore HA Dental Implant System Endosseous Dental Implant System Calmatrix Calcium Sulfate Bone Graf Zygomatic Stage-One Temporary Healing Cap Genesis Implant System 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 RESTORE Dental Implant System Prima Dental Implant System RENOVA Dental Implant System STAGE-1 Dental Implant System 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 STAGE-1 Dental Implant System RESTORE Dental Implant System Prima Dental Implant System Genesis Implant System RENOVA Dental Implant System Genesis Implant System RENOVA Dental Implant System Prima Dental Implant System XP1 Dental Implant System STAGE-1 Dental Implant System RESTORE Dental Implant System PrimaConnex Dental Implant System MAX-TL 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2009-01-13
NUN	Bone Grafting Material, Human Source	Dental	Class 2	872.3930	2007-02-27
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2009-01-13
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2009-01-13
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2009-01-13
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2009-01-13
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2008-10-07
NUN	Bone Grafting Material, Human Source	Dental	Class 2	872.3930	2013-11-12
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2016-11-14
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2016-11-14
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2009-01-13
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2016-11-14
OFY	Dental Implant Surgical Tray	Dental	Class 1	872.3980	2013-01-15
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2013-11-12
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2013-11-12
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2009-01-13
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2016-11-14
LYC	Bone Grafting Material, Synthetic	Dental	Class 2	872.3930	2009-01-13
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2016-11-14
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2009-01-13
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2010-10-29
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2010-10-29
DZA	Drill, Dental, Intraoral	Dental	Class 1	872.4130	2010-10-25
LYC	Bone Grafting Material, Synthetic	Dental	Class 2	872.3930	2009-01-13
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2010-05-17
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2008-10-07
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2009-01-13
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2009-01-13
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2009-01-13
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2009-01-13
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2013-04-17
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2008-10-07
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2009-01-13
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2009-01-13
EJL	Bur, Dental	Dental	Class 1	872.3240	2010-10-25
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2023-05-31
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2023-05-31
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2009-01-13
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2016-11-14
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2016-11-14
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2016-11-14
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2016-11-14
NUN	Bone Grafting Material, Human Source	Dental	Class 2	872.3930	2013-11-12
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2009-01-13
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2010-10-25
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2007-01-23
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2008-10-07
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2008-10-07
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2016-11-14
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2009-01-13
EIL	Gauge, Depth, Instrument, Dental	Dental	Class 1	872.4565	2010-10-25

Official Correspondent

Brian Lanza

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Keystone Dental Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K081806	Idi Biomedical, LLC	IDI IMPLANT SYSTEM	2008-11-07
K120793	Z-Systems AG	Z-LOOK3 EVO SLM	2012-12-21
K130140	Intra-Lock International	INTRA-LOCK OP DENTAL IMPLANT	2013-08-01
K925778	Nobelpharma USA, Inc.	BRANEMARK SYSTEM LAB. AND EDUCATIONAL ACCESSORIES	1993-04-14
K903999	O Co., Inc.	OBUTMENT HB	1992-02-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2020	Implant Direct Sybron Manufacturing, LLC	2	ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
Z-0017-2026	S.I.N. Implant System Ltda Rua Soldador Ocimar Guimaraes da Silva 421 Jardim Analia Franco Sao Paulo Brazil	2	IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT EPIKUT PLUS MT16 3,5X13,0MM, REF: ILM 3513N; IMPLANT EPIKUT PLUS MT16 3,5X15,0MM, REF: ILM 3515N; IMPLANT EPIKUT PLUS MT16 3,8X10,0MM, REF: ILM 3810N; IMPLANT CM16 3,8 X 11MM, REF: ILM 3811N; IMPLANT EPIKUT PLUS MT16 3,8X15,0MM, REF: ILM 3815N; IMPLANT EPIKUT PLUS MT16 4,0X10,0MM, REF: ILM 4010N; IMPLANT EPIKUT PLUS MT16 4,0X11,5MM, REF: ILM 4011N; IMPLANT EPIKUT PLUS MT16 4,0X13,0MM, REF: ILM 4013N; IMP EPIKUT PLUS LONG MT16 4,0X20,0MM, RES: ILM 4020N; IMPLANT EPIKUT PLUS MT16 4,0X8,5MM, RES: ILM 4085N; IMPLANT EPIKUT PLUS MT16 4,5X13,0MM, REF: ILM 4513N; IMPLANT EPIKUT PLUS MT16 4,5X15,0MM, REF: ILM 4515N; IMPLANT EPIKUT PLUS MT16 4,5X8,5MM, REF: ILM 4585N; IMPLANT EPIKUT PLUS MT16 5,0X10,0MM, REF: ILM 5010N; IMPLANT EPIKUT PLUS MT16 5,0X11,5MM, REF: ILM 5011N; IMPLANT EPIKUT PLUS MT16 4,5X10,0MM, REF: ILM 4510N; IMPLANT EPIKUT PLUS MT16 5,0X13,0MM, RES: ILM 5013N; IMPLANT EPIKUT PLUS MT16 5,0X15,0MM, REF: ILM 5015N; IMPLANT EPIKUT PLUS MT16 5,0X8,5MM, REF: ILM 5085N; IMP EPIKUT PLUS LONG MT16 4,0X18,0MM, REF: ILM 4018N; IMP EPIKUT PLUS LONG MT16 3,8X18,0MM, REF: ILM 3818N; IMPLANT EPIKUT PLUS MT16 4,5X11,5MM, REF: ILM 4511N; IMPLANT EPIKUT MT16 4,5X15,0MM, REF: ILM 4515; IMPLANT EPIKUT MT16 4,5X8,5MM, REF: ILM 4585; IMPLANT EPIKUT MT16 3,8X13,0MM, REF: ILM 3813; IMPLANT EPIKUT MT16 3,8X15,0MM, REF: ILM 3815; IMPLANT EPIKUT MT16 5,0X8,5MM, REF: ILM 5085; IMPLANT EPIKUT MT16 3,8X11,5MM, REF: ILM 3811; IMPLANT EPIKUT PLUS MT16 3,8X20,0MM, REF: ILM 3820N; IMPLANT EPIKUT PLUS MT16 4,5X18,0MM, REF: ILM 4518N; IMPLANT UNITITE MORSE COMPACT 6.0X7MM, REF: UCMC 6007N
Z-0018-2020	Implant Direct Sybron Manufacturing, LLC	2	ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product Usage:Implant Direct Sybron Manufacturing LLC s dental implant product line consists of one-piece and two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Z-0019-2020	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	2	Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P
Z-0029-05	Implant Innovations, Inc.	2	EP Healing Abutment- An abutment device is a premanufactured prosthetic component directly connected to the endosseous dental implant.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011936113. Last updated year: 2026. Please use registration number 3011936113 when referencing this establishment in official correspondence.