# K970930: Bilateral Infant Cleft Palate Orthodontic Appliance

- Pathway: 510(k) (Traditional)
- Applicant: Cleft Palate Appliances, Inc.
- Decided: Apr 23, 1997 after 41 days
- Product code: DYJ (Retainer, Screw Expansion, Orthodontic)
- Device class: 1
- Regulation: 21 CFR 872.5410
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Standard maxillary dental and palatal expansion screws: named in the summary without a submission number

## Indications for use
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.

Source page: https://510kreport.com/device/K970930
Methodology: https://510kreport.com/methodology