Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9680348

FEI Number

1000356102

Entity Name

MAKEVALE, LTD.

City/State/Country

WARE, HERTFORDSHIRE, GB

Establishment Address

VALLEY HOUSE, MARSH LANE, WARE, HERTFORDSHIRE SG12 9QP, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MAKEVALE, LTD. (Owner Number: 9008390)

Owner / Operator Contact Address

VALLEY HOUSE, MARSH LANE, --, WARE, HERTFORDSHIRE, GB-NOTA SG12 9QP, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Excel Formula Acrylics

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2007-12-31

Official Correspondent

Samit AHIR

US Agent Details

Geniel Dalton Business: St George Technology, Inc Email: geniel@stgeorgetechnology.com Phone: (910) 3970781

Related Public Records

Same Entity

MAKEVALE, LTD.

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
K800400	Dentsply Intl.	MAXUM DENTURE RESIN	1980-03-12
K033020	Cmp Industries, LLC	IMPAK ACRYLIC REPAIR RESIN LIQUID	2003-12-19

Similar Registrations

Registration Number	Establishment Name	Location
3017374693	STRATASYS LTD - Headquarter	Rehovot Central, IL
2950685	CO-ORAL-ITE DENTAL MFG. CO.	DIAMOND SPRINGS, CA, US
3032727	TALON ACRYLICS, INC.	Winchester, OR, US
3008320092	Shandong Huge Dental Material Corporation	Rizhao Shandong, CN
1410097	GC AMERICA INC.	ALSIP, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9680348. Last updated year: 2026. Please use registration number 9680348 when referencing this establishment in official correspondence.