Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013934196

FEI Number

3013934196

Entity Name

IDOC DENTAL LAB

City/State/Country

Orange, CA, US

Establishment Address

1097 North Batavia St, Orange, CA 92867, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

IDOC Dental Lab (Owner Number: 10059837)

Owner / Operator Contact Address

1097 North Batavia, Orange, CA 92867, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SIMDA Abutment; SIMDA Lab Analog; SIMDA Scan Body Abutment, implant, dental, endosseous Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blank ADD-Z; Alpha+; MaxZir; Natura M; Natura S; NaturaZ HT; NaturaZ Illusion; NaturaZ Series (B16, B20, B42, B60, B98, B100) I-JECT; i-JECT BuilT in System BONE GRAFTING MATERIAL, ANIMAL SOURCE Chairside Zirconia; Perfit FS Dental Zirconia Fully Sintered Block; RAYZir FS EMA Lucitone Digital Print JB Fork, JB Tray DentaGUIDE, DentaTRY STERLINK FPS-15s Plus; STERLOAD Rodin 3D Ceramic Nanohybrid Resin; Rodin Sculpture 2; Rodin Titan Perfit ZR HT Dental Zirconia blank ADD POP BOW Perfit CL

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2024-12-09
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2024-12-09
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2025-04-22
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2024-08-26
EJI	Syringe, Cartridge	Dental	Class 2	872.6770	2024-08-26
NPM	Bone Grafting Material, Animal Source	Dental	Class 2	872.3930	2024-12-09
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2025-04-22
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2024-08-26
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2024-12-10
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2024-08-13
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2024-08-30
MLR	Sterilizer, Chemical	General Hospital	Class 2	880.6860	2024-09-05
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2024-08-27
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2025-04-22
KCR	Facebow	Dental	Class 1	872.3220	2024-08-13
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2025-04-22

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

IDOC Dental Lab

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
K211871	Faico Medical, LLC	FAICO Dental Implant System and CAD/CAM Abutments	2021-11-18
K143656	H.C. Starck Ceramics GmbH	StarCeram® Z-Nature, StarCeram® Z-Smile	2015-07-09
K122391	Medtronic Xomed, Inc.	MEDTRONIC XOMED, INC.	2013-01-10
K800400	Dentsply Intl.	MAXUM DENTURE RESIN	1980-03-12
K033020	Cmp Industries, LLC	IMPAK ACRYLIC REPAIR RESIN LIQUID	2003-12-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2018	Implant Direct Sybron Manufacturing, LLC	2	Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
Z-0017-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For coloring dental porcelain
Z-0018-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For coloring dental porcelain
Z-0019-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For coloring dental porcelain
Z-0020-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse violet, art. no. 681166 Product Usage: For coloring dental porcelain

Similar Registrations

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3011587077	JIANGSU TRAUSIM MEDICAL INSTRUMENT CO.,LTD.	Changzhou Jiangsu, CN
3012121192	DENTAL EVOLUTIONS, INC	Beverly Hills, CA, US
3031529635	TRATE UAB	Kaunas Kauno Apskritis, LT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013934196. Last updated year: 2026. Please use registration number 3013934196 when referencing this establishment in official correspondence.