Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002706372

FEI Number

3002706372

Entity Name

DRAKE PRECISION DENTAL LABORATORY, INC.

City/State/Country

CHARLOTTE, NC, US

Establishment Address

8510 Crown Crescent Ct, CHARLOTTE, NC 28227, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

DRAKE PRECISION DENTAL LABORATORY (Owner Number: 9098906)

Owner / Operator Contact Address

8510 CROWN CRESCENT CT., --, Charlotte, NC 28227, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

TAP 3 TL ELASTIC MANDIBULAR ADVANCEMENT (EMA) APPLIANCE Bialex Easy Lead-Check

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NSL	Dentures, Full	Unknown	Class N	N/A	2012-12-04
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2009-04-29
NSK	Dentures, Partial	Unknown	Class N	N/A	2012-12-04
NXC	Aligner, Sequential	Dental	Class 2	872.5470	2020-12-18
NSO	Restoration, Porcelain-Fused-To-Metal	Unknown	Class N	N/A	2012-12-04
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2018-12-18
NSQ	Restoration, Base Metal	Unknown	Class N	N/A	2012-12-04
NSP	Restoration, Porcelain	Unknown	Class N	N/A	2012-12-04
NSJ	Restoration, Noble Metal	Unknown	Class N	N/A	2012-12-04
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2011-05-31
JKL	Acid, Delta-Aminolevulinic, Ion-Exchange Columns With Colorimetry	Clinical Chemistry	Class 1	862.1060	2026-04-18

Official Correspondent

ROBERT SAVAGE JR.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

DRAKE PRECISION DENTAL LABORATORY

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
K122391	Medtronic Xomed, Inc.	MEDTRONIC XOMED, INC.	2013-01-10

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.

Similar Registrations

Registration Number	Establishment Name	Location
3019909974	SHENZHEN HLD DENTAL&TECHNOLOGY CO.,LTD	Shenzhen Guangdong, CN
3030516430	DANTECH DIGITAL DENTAL SOLUTIONS PRIVATE LIMITED	Chennai Tamil Nadu, IN
3004086183	Royal Dental Lab	Shenzhen Guangdong, CN
3011714596	HK ADVANCED DENTAL DIGITAL LIMITED	Tsuen Wan, N.T, HK
3009093236	PERFECT CROWN DENTAL LAB	Maspeth, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002706372. Last updated year: 2026. Please use registration number 3002706372 when referencing this establishment in official correspondence.