ORTHO-TAIN, INC.

FDA Device Registration & Listing · Toa Alta, PR, US · Registration 2649784

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2649784
FEI Number
2649784
Entity Name
ORTHO-TAIN, INC.
City/State/Country
Toa Alta, PR, US
Establishment Address
CARR 861, K.M. 5.0, BARRIO, PINAS, Toa Alta, PR 00953, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
ORTHO-TAIN, INC. (Owner Number: 9914028)
Owner / Operator Contact Address
CARR R 861, K.M. 5.O, BARRIO PINAS, Toa Alta, PR 00953, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

SOFTEE APPLIANCE STOP SHOCK HABIT-CORRECTOR SPORTGUARD INTERIM "G" RETAINER SNORE-CURE HAWLEY-FORM CLASS III GUIDE PERFIT BUMPER

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DYO Band, Material, Orthodontic Dental Class 1 872.5410 2001-06-14
DZC Wire, Orthodontic Dental Class 1 872.5410 2001-06-14

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ORTHO-TAIN, INC.
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2649784. Last updated year: 2026. Please use registration number 2649784 when referencing this establishment in official correspondence.
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