Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Syntec Orthodontic Mini Screw Extended System

K-Number: K202790 · 2021-09-17

ApplicantSyntec Scientific Corporation
Decision Date2021-09-17
Product CodeOAT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Syntec Orthodontic Mini Screw Extended System is the device name listed in this FDA 510(k) record. The listed applicant is Syntec Scientific Corporation. It received FDA 510(k) clearance on 2021-09-17 under 510(k) number K202790. The device is classified under product code OAT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Syntec Orthodontic Mini Screw Extended System?

Syntec Orthodontic Mini Screw Extended System is a medical device that received FDA 510(k) clearance on 2021-09-17. The listed applicant is Syntec Scientific Corporation. The 510(k) number is K202790.

When did Syntec Orthodontic Mini Screw Extended System receive FDA 510(k) clearance?

Syntec Orthodontic Mini Screw Extended System received FDA 510(k) clearance on 2021-09-17, under 510(k) number K202790.

Who is the listed applicant for Syntec Orthodontic Mini Screw Extended System?

The FDA 510(k) record lists Syntec Scientific Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Syntec Orthodontic Mini Screw Extended System?

The FDA product code for Syntec Orthodontic Mini Screw Extended System is OAT.

Other records listing Syntec Scientific Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K202935Syntec Femoral Nail Extended SystemK200933Syntec Non-Sterile Steinmann Pins SystemK191617Syntec Tibial Nail SystemK181296Syntec Femoral Nail SystemK161327SYNTEC HUMERAL NAIL SYSTEM

Related Devices (Code: OAT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260268OrthoEasy Pal; OrthoEasy Pal Long NeckBernhard Förster GmbH (Bernhard Foerster Ltd.)K242944Leone Orthodontic Implant TAD (Temporary Anchorage Device)Leone S.P.A.K231502Mini ScrewsProimtech Saglik Urunleri Anonim SirketiK231913T-FITTechwin Co., Ltd.K222245ACR Screw SystemBiomaterials Korea, Inc.K202163Mico One Orthodontic ScrewZe Fang Technology Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑