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3D Medical Technologies Inc.: FDA-registered device maker in Maple Ridge British Columbia, Canada, 12 PMA approvals

Name: 3D Medical Technologies Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

3D Medical Technologies Inc. is registered with the FDA (registration 3045078914) in Maple Ridge British Columbia, Canada. It lists 3 device types. The FDA files 12 PMA approvals under its listings, the newest dated October 19, 2017. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3045078914
Address: 12647 238 St, Maple Ridge British Columbia, Canada, V4R 1P9
Owner or operator: 3D Medical Technologies Inc. (10095560)
Roles: Exporter to the US, Foreign private label distributor
First device listed: March 30, 2026
Registered through: 2026
Brand names listed: BELOTERO BALANCE, BELOTERO BALANCE (SAMPLE), BELOTERO BALANCE DERMAL FILLER, BOLOTERO BALANCE INJECTABLE DERMAL FILLER, Belotero Balance (+) Lidocaine, Belotero Balance (+) Lidocaine Dermal Filler, Belotero Balance + Lidocaine, Belotero Balance + Lidocaine Dermal Filler and more

Devices it lists

Device	Product code	Class	Role	Source
Agent, Bulking, Injectable For Gastro-Urology Use	LNM	3	Exporter to the US, Foreign private label distributor	accessdata.fda.gov
Implant, Dermal, For Aesthetic Use	LMH	3	Exporter to the US, Foreign private label distributor	accessdata.fda.gov
Implant, Dermal, For Aesthetic Use In The Hands	PKY	3	Exporter to the US, Foreign private label distributor	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
October 19, 2017	P170002	RHA 2, RHA 3, RHA 4	LMH	55	August 31, 2026	accessdata.fda.gov
August 4, 2017	P160042	REVANESSE ULTRA	LMH	24	October 14, 2026	accessdata.fda.gov
December 9, 2016	P140029	Restylane Refyne, Restylane Defyne	LMH	51	September 18, 2026	accessdata.fda.gov
October 22, 2013	P110033	JUVEDERM VOLUMA XC	LMH	97	August 28, 2026	accessdata.fda.gov
November 14, 2011	P090016	BELOTERO BALANCE	LMH	60	May 3, 2026	accessdata.fda.gov
December 22, 2006	P050052	RADIESSE INJECTABLE IMPLANT	LMH	169	June 26, 2026	accessdata.fda.gov
December 22, 2006	P050037	RADIESSE 1.3CC AND 0.3CC	LMH	147	June 26, 2026	accessdata.fda.gov
June 2, 2006	P050047	JUVEDERM 24HV, JUVEDERM 30 AND JUVEDERM 30HV GEL IMPLANTS	LMH	101	August 28, 2026	accessdata.fda.gov
November 10, 2005	P040047	COAPTITE	LNM	76	June 26, 2026	accessdata.fda.gov
March 25, 2005	P040024	RESTYLANE INJECTABLE GEL	LMH	132	March 12, 2026	accessdata.fda.gov
August 3, 2004	P030050	SCULPTRA AND SCULPTRA AESTHETIC	LMH	54	September 17, 2026	accessdata.fda.gov
December 12, 2003	P020023	RESTYLANE INJECTABLE GEL	LMH	12	October 21, 2005	accessdata.fda.gov

Compare with other makers

Updated August 31, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.