Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008582406

FEI Number

3008582406

Entity Name

OPA DENTAL, LLC

City/State/Country

Huntington, WV, US

Establishment Address

105 Whitaker blvd, Huntington, WV 25701, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Opa Dental, LLC (Owner Number: 10033786)

Owner / Operator Contact Address

105 Whitaker blvd, Huntington, WV 25701, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K141723

PMA Number

N/A

All Registered Proprietary Names

Ceramic grinder Rubber polisher Silicone polisher diamond burs

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	2021-02-05
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2021-04-14
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2015-10-28
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2015-12-15
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2023-12-05
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2018-11-06
EJQ	Wheel, Polishing Agent	Dental	Class 1	872.6010	2013-08-07
EHL	Point, Abrasive	Dental	Class 1	872.6010	2013-08-07
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2021-02-05
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2023-12-05
EHJ	Disk, Abrasive	Dental	Class 1	872.6010	2013-08-07
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2018-10-19
ELW	Material, Impression	Dental	Class 2	872.3660	2018-09-18
EMA	Cement, Dental	Dental	Class 2	872.3275	2021-06-03
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2021-06-03
EJL	Bur, Dental	Dental	Class 1	872.3240	2013-08-07
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2015-09-13

Official Correspondent

Lee Gorham

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Opa Dental, LLC

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
K143656	H.C. Starck Ceramics GmbH	StarCeram® Z-Nature, StarCeram® Z-Smile	2015-07-09
K952662	Jeneric/Pentron, Inc.	COMP=FLOW	1995-08-28
K171147	Bisco, Inc.	REVEAL Bulk	2017-08-04
K770922	Espe GmbH (Us)	DENTAL RESTORATIVE IN CAPSULES	1977-06-01
K153476	Kuraray Noritake Dental, Inc.	KATANA AVENCIA Block	2016-08-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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
Z-0021-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color A1 60ml, art. no. 681050, Product Usage: For coloring dental porcelain

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008582406. Last updated year: 2026. Please use registration number 3008582406 when referencing this establishment in official correspondence.