510(k) Report

510(k) · Cleared

Cleared

Bilateral Infant Cleft Palate Orthodontic Appliance

K970930510(k) TraditionalCleared Apr 23, 199741-day reviewClass I21 CFR 872.5410

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

Cleft Palate Appliances, Inc. · DYJ Retainer, Screw Expansion, Orthodontic

Cleared on Apr 23, 1997 after a 41-day review. The FDA summary names its predicate without a number.

Decided
Apr 23, 1997
Review
41 days
Class
Class I
Product code
DYJ
Recalls
None
Predicates
0

The FDA summary names its predicate without a number.

FIG. 1 — Lineage of K970930Source: FDA 510(k) database · 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.

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  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (1)

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
*—Standard maxillary dental and palatal expansion screws
Named without a submission number
—

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.

How does its category compare?

All DYJ devices

DYJ Retainer, Screw Expansion, Orthodontic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DYJ

FDA has decided no DYJ device since 2007.

Median 510(k) review, days · DYJ

Too few DYJ 510(k)s in any year since 2007 to give a median.

Recalls per year · DYJ

3in 2022

2009: 12022: 3
2007high 3 (2022) · low 0 (2007)2026

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

Adverse event reports per year · DYJ

1in 2025

2007: 62008: 32009: 22010: 12011: 42012: 32014: 12015: 22016: 22017: 22018: 122019: 92020: 32021: 62022: 52023: 112024: 32025: 1
2007high 12 (2018) · low 0 (2013)2025

MAUDE reports naming product code DYJ, 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
20070—06
20080—03
20090—12
20100—01
20110—04
20120—03
20130—00
20140—01
20150—02
20160—02
20170—02
20180—012
20190—09
20200—03
20210—06
20220—35
20230—011
20240—03
20250—01
20260—0—

What is it indicated for?

Infants born with complete bilateral clefts of the lip and palate have an associated protrusion of the premaxillary segment. The amount of protrusion from the molar and cuspids segments (maxillary segments) varies between 8 and 18 mm. Treatment of the protruding premaxillary segment is one of the most difficult problems in orthodontics and plastic surgery. The bilateral cleft palate appliance is indicated for patients with more than about five…

Read the full statement (425 words)

Infants born with complete bilateral clefts of the lip and palate have an associated protrusion of the premaxillary segment. The amount of protrusion from the molar and cuspids segments (maxillary segments) varies between 8 and 18 mm. Treatment of the protruding premaxillary segment is one of the most difficult problems in orthodontics and plastic surgery. The bilateral cleft palate appliance is indicated for patients with more than about five millimeters of protrusion. It provides the most predictable and rapid method for repositioning the premaxillary segment into the normal dental arch prior to surgical correction of the lip. With the premaxillary segment repositioned it is possible to repair both sides of the lip in one operation. The lip repair can be performed without tension on the lip sutures, thus minimizing scar formation. Surgical repair of the dental alveolar process is also possible and when performed it reduces the incidence of palatal fistulas in the growing child.

Sometimes there is minimal premaxillary protrusion but the maxillary segments are constricted or collapsed. Expansion of the maxillary segments can be accomplished using the bilateral cleft palate appliance.

Infants with unilateral complete or incomplete clefts of the lip and palate usually have quite severe nasal asymmetry both laterally and in the antero-posterior dimension. This is related to malformation of the dentoalveolar maxillary segments. The cleft maxilla appears to be retruded and the noncleft premaxillary segment shows a variable degree of protrusion. If the cleft is complete there is usually a wide cleft of the alveolar process in the range of 8 to 24 mm. Surgical correction of the nasal asymmetry is extremely difficult and after the first reconstructive surgical treatment there is frequently residual nasal deformity which may persist until teenage and still be quite difficult to correct.

The unilateral cleft palate appliance is indicated for the newborn infant with a complete lip and palate cleft or one that is nearly complete. It will have the effect of treating the asymmetry of the nasal alar bases so that they are level anteroposteriorly. It will also bring the dentoalveolar segments into alignment. The correction of the dental segments is a very significant benefit because the parts of the cleft lip can be brought together and the lip reconstructed with much less tension on the repaired area. Reconstruction of the nose is very much facilitated when the asymmetry of the nasal alar bases is first eliminated. Treatment with the unilateral appliance usually provides an alignment of the dentoalveolar ridge that permits primary reconstruction of the alveolar process at the first surgical treatment.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Cite this page

510(k) Report. “K970930: Bilateral Infant Cleft Palate Orthodontic Appliance.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970930

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