Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016986305

FEI Number

3016986305

Entity Name

SHOWCASE DENTAL LAB LLC

City/State/Country

Punta Gorda, FL, US

Establishment Address

25560 Technology Blvd, Punta Gorda, FL 33950, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Showcase Dental Lab LLC (Owner Number: 10075185)

Owner / Operator Contact Address

25560 Technology Blvd., Punta Gorda, FL 33950, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Ortho Products Porcelain Restoration Implant Restoration Noble Metal Restoration Base Metal Restoration Bleaching Tray Dental Product Denture, Acrylic Teeth, Denture, Partial Denture Preformed Crown, Crown, Porcelain Crown Alloy

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2023-08-09
NSP	Restoration, Porcelain	Unknown	Class N	N/A	2020-06-14
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2023-08-09
NSJ	Restoration, Noble Metal	Unknown	Class N	N/A	2020-06-14
NSQ	Restoration, Base Metal	Unknown	Class N	N/A	2020-06-14
KMT	Tray, Fluoride, Disposable	Dental	Class 1	872.6870	2023-08-09
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2020-06-14
ELZ	Crown, Preformed	Dental	Class 1	872.3330	2020-06-14
EJT	Alloy, Gold-Based Noble Metal	Dental	Class 2	872.3060	2023-08-09

Official Correspondent

Victor Frattura

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Showcase Dental Lab 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
K112640	Ormco Corp.	HYPERELASTIC WIRE	2011-11-16
K070591	Union Dental S.A./Unidesa.Odi	REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH	2007-05-11
K915276	Nobelpharma USA, Inc.	DENTURE PLASTIC TEETH,76 ELM	1992-02-03
K915626	Ivoclar North America, Inc.	EZ GOLD	1992-02-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0014-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0015-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0016-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0017-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment PCA, Cat. No. 30-70105 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016986305. Last updated year: 2026. Please use registration number 3016986305 when referencing this establishment in official correspondence.