Data / Medical devices / United States / Idoc Dental Lab

Idoc Dental Lab: FDA-registered device maker in Orange, CA, United States, 5 510(k) clearances

Name: Idoc Dental Lab FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Idoc Dental Lab is registered with the FDA (registration 3013934196) in Orange, CA, United States. It lists 12 device types. The FDA files 5 510(k) clearances under its listings, the newest dated September 13, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3013934196
Address: 1097 North Batavia St, Orange, CA, United States, 92867
Owner or operator: IDOC Dental Lab (10059837)
Roles: Contract manufacturer, Repackager or relabeler
First device listed: August 13, 2024
Registered through: 2026
Brand names listed: ADD POP BOW, ADD-Z; Alpha+; MaxZir; Natura M; Natura S; NaturaZ HT; NaturaZ Illusion; NaturaZ Series (B16, B20, B42, B60, B98, B100), Abutment, implant, dental, endosseous, BONE GRAFTING MATERIAL, ANIMAL SOURCE, Chairside Zirconia; Perfit FS Dental Zirconia Fully Sintered Block; RAYZir FS, Chairside Zirconia; Perfit FS; RAYZir FS, DenQ Sub Multi-unit Abutment(Angled-1) DSMAR493017OS, DenQ Sub Multi-unit Abutment(Angled-1) DSMAR494017OS and more

Devices it lists

Device	Product code	Class	Role	Source
Abutment, Implant, Dental, Endosseous	NHA	2	Repackager or relabeler	accessdata.fda.gov
Accessories, Implant, Dental, Endosseous	NDP	1	Contract manufacturer	accessdata.fda.gov
Bone Grafting Material, Animal Source	NPM	2	Repackager or relabeler	accessdata.fda.gov
Device, Anti-Snoring	LRK	2	Contract manufacturer	accessdata.fda.gov
Facebow	KCR	1	Repackager or relabeler	accessdata.fda.gov
Implant, Endosseous, Root-Form	DZE	2	Repackager or relabeler	accessdata.fda.gov
Material, Impression Tray, Resin	EBH	1	Repackager or relabeler	accessdata.fda.gov
Material, Tooth Shade, Resin	EBF	2	Contract manufacturer	accessdata.fda.gov
Powder, Porcelain	EIH	2	Contract manufacturer	accessdata.fda.gov
Resin, Denture, Relining, Repairing, Rebasing	EBI	2	Contract manufacturer	accessdata.fda.gov
Sterilizer, Chemical	MLR	2	Repackager or relabeler	accessdata.fda.gov
Syringe, Cartridge	EJI	2	Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 13, 2024	K240977	DenQ Sub SLA Implant System	DZE	Substantially Equivalent	Denq	accessdata.fda.gov
October 13, 2023	K231672	S1	NPM	Substantially Equivalent	Medpark Co., Ltd.	accessdata.fda.gov
May 24, 2023	K223663	SIMDA Abutment	NHA	Substantially Equivalent	Simda Co., Ltd.	accessdata.fda.gov
October 22, 2021	K212200	STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette	MLR	Substantially Equivalent	Plasmapp Co,., Ltd.	accessdata.fda.gov
August 8, 2012	K112787	KERATOR	NHA	Substantially Equivalent	Kj Meditech Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated September 13, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.