Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010324114

FEI Number

3010324114

Entity Name

CRANE DENTAL LABORATORY

City/State/Country

Rochester, NY, US

Establishment Address

3515 Buffalo Rd Suite 30, Rochester, NY 14624, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Crane Dental Laboratory (Owner Number: 10044573)

Owner / Operator Contact Address

3515 BUFFALO ROAD, STE 30, Rochester, NY 14624, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K140429

PMA Number

N/A

All Registered Proprietary Names

Respire Blue Series Lamberg SleepWell Sapphire Dorsal Comfort Fit Crane Acrylic Herbst Appliance Sapphire Herbst Appliance

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2013-06-27
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2014-07-09
LQZ	Device, Jaw Repositioning	Dental	Class 2	872.5570	2014-07-09
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2019-10-07
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2014-11-24

Official Correspondent

Kevin Crane

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Crane 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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010324114. Last updated year: 2026. Please use registration number 3010324114 when referencing this establishment in official correspondence.