Manufacturer registered with FDA

Drake Precision Dental Laboratory, Inc.

Charlotte, NC, United States. Lists 3 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator9098906Contract manufacturerManufacturerRepacker / relabelerSpecification developer

Device types listed: 3
Brands and models: 3
510(k) clearances: 12020–2020
Markets registered in: 1United States
Establishments: 1United States

510(k) clearances per year, 2007–2026

Devices listed with FDA

What Drake Precision Dental Laboratory, Inc. currently lists, by FDA device type, with the brand and model names on the listing.

Device type	Category	Role	Brands and models	Listed since
Anti-Snoring DeviceLRK · Class 2	Anti-snoring & jaw-repositioning devices	Maker	BIALEX Lead Screen CheckELASTIC MANDIBULAR ADVANCEMENT (EMA) APPLIANCETAP 3 TL	2009
Endosseous Dental Implant AccessoriesNDP · Class 1	Implant instruments & surgical kits	Lister	—	2018
Sequential AlignerNXC · Class 2	Clear aligners	Maker	—	2020

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names Drake Precision Dental Laboratory, Inc. as the applicant.

Decided	510(k)	Device	Device type
9 Nov 2020	K200005	Concinnity Aligners	NXC Sequential Aligner

Registered establishments

Establishment	Location	What it does
DRAKE PRECISION DENTAL LABORATORY, INC.FDA reg. 3002706372	CHARLOTTE, NC, United States	Contract manufacturer, Manufacturer, Repacker / relabeler, Specification developer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 9098906). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.