Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014425175

FEI Number

3014425175

Entity Name

Sharp Detail Orthodontic Laboratory S DE EL DE CV

City/State/Country

Tijuana Baja California, MX

Establishment Address

Calle 5TA 7928 Interior 7 y 11, Tijuana Baja California 22000, MX

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Sharp Detail Orthodontic Laboratory (Owner Number: 10055967)

Owner / Operator Contact Address

7853 El cajon Blvd #J, La Mesa, CA 91942, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BAND, PREFORMED, ORTHODONTIC TUBE, ORTHODONTIC WIRE, ORTHODONTIC WAX, DENTAL, INTRAORAL MAINTAINER, SPACE PREFORMED, ORTHODONTIC POSITIONER, TOOTH, PREFORMED BRACKET, METAL, ORTHODONTIC CLASP, PREFORMED RETAINER, SCREW EXPANSION, ORTHODONTIC Band, elastic, orthodontic

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ECM	Band, Preformed, Orthodontic	Dental	Class 1	872.5410	2017-10-23
DZD	Tube, Orthodontic	Dental	Class 1	872.5410	2018-03-12
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2017-10-23
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	2017-10-23
DYT	Maintainer, Space Preformed, Orthodontic	Dental	Class 1	872.5525	2017-10-23
KMY	Positioner, Tooth, Preformed	Dental	Class 1	872.5525	2017-10-23
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2018-03-12
EHP	Clasp, Preformed	Dental	Class 1	872.3285	2017-10-23
DYJ	Retainer, Screw Expansion, Orthodontic	Dental	Class 1	872.5410	2017-10-23
ECI	Band, Elastic, Orthodontic	Dental	Class 1	872.5410	2018-03-12

Official Correspondent

No official correspondent registered.

US Agent Details

Jerry Doane Business: Pragmatic Compliance LLC dba FDAbasics Email: usagent@fdabasics.com Phone: (716) 7750533

Related Public Records

Same Entity

Sharp Detail Orthodontic 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
K112640	Ormco Corp.	HYPERELASTIC WIRE	2011-11-16
K894358	Ormco Corp.	LUMINA ORTHODONTIC BRACKET	1989-09-15
K925012	American Orthodontics	PLASTIC CHAIN	1993-09-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2012	Biomet Microfixation, Inc.	1	Biomet Microfixation outer packaging labeled in part:"REF: SP-2411*RUBBER BAND, LATEX FREE SMALL, HEAVY, 300/PACKAGE 4MM, (3/16" INNER DIAMETER) NON LATEX ELASTICS LOT 307850DISTRIBUTED BY: BIOMET MICROFIXATION 1520 Tradeport Drive, Jacksonville, FL 32218 USA www.biometmicrofixation.com." Inner Vendor/Manufacturer Label labeled in part:"H4 Elastics 4mm (3/16") Heavy 4 oz. REF 11-102-04Manufactured for DENTSPLY GAC INTERNATIONAL DENTSPLY INTERNATIONAL, INC. Phone 631-419-1700 Fax 631-419-1599 355 Knickerbocker Avenue Bohemia NY 11716 USAMediMark Europe BP2332 F-38033 Grenoble Cedex 2. FranceLOT 82936-32 QTY:100 pk use by 2012-07 Made in USA ISSUED DATE 2009-04 GN**" Elastic bands used as elastomeric ties for ligation that facilitate treatment of fracture of the mandible and maxilla. They are commonly used with braces or arch bar wire.

Similar Registrations

Registration Number	Establishment Name	Location
3014054179	ASO INTERNATIONAL MANILA, INC.	Cavite,Region IVa,, PH
3015272949	Ormco Corporation	Brea, CA, US
3008317118	BEST VALUE CERAMICS INC	Wyoming, PA, US
3015337428	GUANGZHOU CHEER-U MATERIAL TECHNOLOGY CO., LTD	Guangzhou Guangdong, CN
1833132	G & H Wire Company	Franklin, IN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014425175. Last updated year: 2026. Please use registration number 3014425175 when referencing this establishment in official correspondence.