Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009161287

FEI Number

3009161287

Entity Name

PRECISION DENTAL PRODUCTS, LLC

City/State/Country

Draper, UT, US

Establishment Address

13925 Maple Hollow Cir, Draper, UT 84020, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Repack or Relabel Medical Device

Owner / Operator

Precision Dental Products, LLC (Owner Number: 10037240)

Owner / Operator Contact Address

13925 S. Maple Hollow Circle, Draper, UT 84020, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

OneBite

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2011-06-27

Official Correspondent

Juan Olivier

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Precision Dental Products, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3013443455	VAMCO, LLC	Albuquerque, NM, US
3030268763	OWL DENTAL	San Leandro, CA, US
3015168527	Shenzhen Senlede Technologies Co., Ltd	Shenzhen Guangdong, CN
3014268398	LLRN PERSONAL CARE (SHENZHEN) CO.,LTD	shenzhen Guangdong, CN
3016170492	SHANGHAI ALWINGS MEDICAL INSTRUMENT CO.,LTD.	Shanghai, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009161287. Last updated year: 2026. Please use registration number 3009161287 when referencing this establishment in official correspondence.