510(k) Report

510(k) · Cleared

Cleared

Orthodontic Plastic Brackets and Accessories

K180718510(k) TraditionalCleared Oct 30, 2018225-day reviewClass II21 CFR 872.5470

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Tomy, Inc. · DYW Bracket, Plastic, Orthodontic

Cleared on Oct 30, 2018 as substantially equivalent to K092030 (Dentsply Interntional, 2009) and 3 other predicates after a 225-day review. Its family tree reaches back 5 generations to 1985.

Decided
Oct 30, 2018
Review
225 days
Class
Class II
Product code
DYW
Recalls
None
Predicates
4

Its longest line of descent runs back 5 generations to K852179 (1985). 9 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2008: 1 other ancestor2005: 1 other ancestor2004: 1 other ancestor1994: 1 other ancestorK852179 · Ceramic Orthodonit Appliance · Gac Intl., Inc. · 1985K042178 · Orthodontic Ceramic Brackets · Dentsply Intl. · 2004K082974 · Mystique MB Ceramic Brackets · Dentsply Interntional · 2008×2: 2 generations cleared close together, K090454 (2009), K092030 (2009) 19851990199520002005201020152020
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 1 other ancestor K092030 · Elation MB Metal Reinforced Plastic Bracket · Dentsply Interntional · 2009K090454 · Allure MB Ceramic Brackets · Dentsply Interntional · 2009K082974 · Mystique MB Ceramic Brackets · Dentsply Interntional · 2008K042178 · Orthodontic Ceramic Brackets · Dentsply Intl. · 2004K852179 · Ceramic Orthodonit Appliance · Gac Intl., Inc. · 1985−50
  1. Root · 5 generations backK852179 Ceramic Orthodonit ApplianceGac Intl., Inc. · 1985
  2. 4 generations backK042178 Orthodontic Ceramic BracketsDentsply Intl. · 2004
  3. 3 generations backK082974 Mystique MB Ceramic BracketsDentsply Interntional · 2008
  4. 2 generations backK090454 Allure MB Ceramic BracketsDentsply Interntional · 2009
  5. 1 generation backK092030 Elation MB Metal Reinforced Plastic BracketDentsply Interntional · 2009
  6. This deviceK180718 Orthodontic Plastic Brackets and AccessoriesTomy, Inc. · 2018
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K852179Ceramic Orthodonit ApplianceGac Intl., Inc.1985—
−4K042178Orthodontic Ceramic BracketsDentsply Intl.2004—
−3K082974Mystique MB Ceramic BracketsDentsply Interntional2008—
−2K090454Allure MB Ceramic BracketsDentsply Interntional2009—
−1K092030Elation MB Metal Reinforced Plastic BracketDentsply Interntional2009—
0 (this device)K180718Orthodontic Plastic Brackets and AccessoriesTomy, Inc.2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
200410
200510
200810
FIG. 1 — Lineage of K180718, 1985–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DYW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DYW device

  1. #1 K252760 Carriere® Motion Pro® Clear Bite Correctorscore 10.4 · 1 generation · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K092030Elation MB Metal Reinforced Plastic Bracket
Summary page 4
…c plastic bracket (21 CFR 872.5470) Regulatory Class: II Product Code: DYW III. PREDICATE AND REFERENCE DEVICES DENTSPLY Elation MB Metal Reinforced Plastic Brackets, K092030 (Primary Predicate) CDB Corporation CDB Clip, K080906 GESTENCO INTERNATIONAL AB Orthodontic Polymer Composite Bracket, K053055 DE…
Dentsply Interntional2009—
*K080906CDB Clip
Summary page 4
…II Product Code: DYW III. PREDICATE AND REFERENCE DEVICES DENTSPLY Elation MB Metal Reinforced Plastic Brackets, K092030 (Primary Predicate) CDB Corporation CDB Clip, K080906 GESTENCO INTERNATIONAL AB Orthodontic Polymer Composite Bracket, K053055 DENTSPLY NEO-CLIP Orthodontic Bracket Accessory, K042905…
Cdb Corporation20081
*K053055Orthodontic Polymer Composite Bracket
Summary page 4
…tion MB Metal Reinforced Plastic Brackets, K092030 (Primary Predicate) CDB Corporation CDB Clip, K080906 GESTENCO INTERNATIONAL AB Orthodontic Polymer Composite Bracket, K053055 DENTSPLY NEO-CLIP Orthodontic Bracket Accessory, K042905 IV. DEVICE DESCRIPTION The ORTHODONTIC PLASTIC BRACKETS are designed t…
Gestenco International AB2005—
*K042905Neo-Clip Orthodontic Bracket Accessory
Summary page 4
…ry Predicate) CDB Corporation CDB Clip, K080906 GESTENCO INTERNATIONAL AB Orthodontic Polymer Composite Bracket, K053055 DENTSPLY NEO-CLIP Orthodontic Bracket Accessory, K042905 IV. DEVICE DESCRIPTION The ORTHODONTIC PLASTIC BRACKETS are designed to move teeth to improve their alignment. The ORTHODONTIC…
Dentsply Intl.2004—

Also cleared against K092030: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 33 years and passes through 4 companies; a new generation was cleared every 4.2 years on median.
  • 1 of the 9 ancestors has a recall of any class.
  • 1 other device also cites its predicate K092030.

How does its category compare?

All DYW devices

DYW Bracket, Plastic, Orthodontic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · DYW

2in 2025

2007: 22008: 12009: 22010: 12011: 12012: 12013: 22014: 12016: 32018: 22020: 12025: 2
2007high 3 (2016) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DYW

372in 2016

2016: 372 days median
2007high 372 (2016)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DYW

2in 2011

2011: 2
2007high 2 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DYW

1in 2017

2007: 22014: 42015: 42017: 1
2007high 4 (2014) · low 0 (2008)2025

MAUDE reports naming product code DYW, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—02
20081—00
20092—00
20101—00
20111—20
20121—00
20132—00
20141—04
20150—04
2016337200
20170—01
20182—00
20190—00
20201—00
20210—00
20220—00
20230—00
20240—00
20252—00
20260—0—

What is it indicated for?

ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES are indicated for orthodontic movement of natural teeth.

Indications for use as stated in the FDA summary.

Also cleared against K092030

1 other device cites the same predicate.

  • K140807Composite Orthodontic BracketsOrtho Specialties · 2014

More from Tomy, Inc.

4 FDA decisions under this applicant name. See the company

  • K160615Orthodontic Ceramic Brackets 1.1Tomy, Inc. · 2016
  • K123092Ceramin Brackets ZTomy, Inc. · 2012
  • K123094Orthodontic Ceramic BracketsTomy, Inc. · 2012

Recent decisions in DYW

The DYW category page

  • K252760Carriere® Motion Pro® Clear Bite CorrectorOrtho Organizers, Inc. · 2025
  • K251196Composite Orthodontic Brackets and ButtonsEc Certification Service GmbH · 2025
  • K201940Braces on Demand BracketBraces on Demand, Inc. · 2020
  • K182338Blue Sky Bio Computerized Orthodontic Bracket SystemBlue Sky Bio · 2018
  • K160720Carriere Motion Clear Class IIOrtho Organizers, Inc. · 2016

https://510kreport.com/device/K180718 · printed Nov 5, 2026

Cite this page

510(k) Report. “K180718: Orthodontic Plastic Brackets and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K180718

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026