Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014316197

FEI Number

3014316197

Entity Name

PLACECOL S.A

City/State/Country

funza Cundinamarca, CO

Establishment Address

autopista medellin km 7 parque industrial celta trade park, bodega 109, funza Cundinamarca 250027, CO

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

PLACECOL S.A (Owner Number: 10056860)

Owner / Operator Contact Address

carrera 17 166 31, km 1,0 via siberia cota robles 4, bogota, CO-CUN 110131, CO

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

mestrual cup exempt exempt exempt exempt exempt

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HHE	Cup, Menstrual	Obstetrics/Gynecology	Class 2	884.5400	2020-12-10
NXZ	Dental Hygiene Kit	Dental	Class 1	872.6855	2018-01-23
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2018-01-23
JET	Pick, Massaging	Dental	Class 1	872.6650	2018-04-04
JES	Floss, Dental	Dental	Class 1	872.6390	2018-01-23
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	2018-01-23

Official Correspondent

No official correspondent registered.

US Agent Details

Luis Cardenas Business: Orthodental USA corp Email: sales@orthodentalusa.com Phone: (954) 6016832

Related Public Records

Same Entity

PLACECOL S.A

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
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11
K821629	Moyco Industries, Inc.	FIXIDENT	1982-06-14
K882164	Arthur Blank & Co., Inc.	FLOSS CARD	1988-06-10

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014316197. Last updated year: 2026. Please use registration number 3014316197 when referencing this establishment in official correspondence.