Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Specialty Appliance Works with 10 device recalls and 3 510(k) clearances. The most recent is a 510(k) clearance dated Jan 3, 2019: Clear Image Aligners.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jan 3, 2019 | Clear Image AlignersK183643 · NXC | 510(k) clearances |
| Mar 9, 2015 | TS ROC Crown Component 4UR (5/pk), TS ROC Crown Component 5UR (5/pk), TS ROC Crown Component 6UR (5/pk), TS ROC Crown Component 7UR (5/pk), Class II · The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. | Device recalls |
| Mar 9, 2015 | Specialty MiniScope Mech. Set Size 18, Specialty MiniScope Mech. Set Size 21, and Specialty MiniScope Mech. Set Size 24 A Herbst Appliance Class II · The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. | Device recalls |
| Mar 9, 2015 | TS Herbst Nuts with Backing (10/pk) and TS Herbst Nuts Universal (10/pk) A Herbst Appliance is used to affect changes in the skeletal relatClass II · The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. | Device recalls |
| Mar 9, 2015 | MiniScope Hst ROC Crown 15 Patient Kit, and MiniScope Herbst Crown 15 Patient Kit A Herbst Appliance is used to affect changes in the skeleClass II · The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. | Device recalls |
| Mar 9, 2015 | M-4 Mechanism Set 16 mm and M-4 Mechanism Set 19 mm A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusClass II · The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. | Device recalls |
| Mar 9, 2015 | HTM Mechanism Set Set 16, HTH Mechanism Set Size 18, HTH Mechanism Set Size 21 and HTH Mechanism Set Size 24 A Herbst Appliance is used to Class II · The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. | Device recalls |
| Mar 9, 2015 | LR Telescoping Cantilever Arms (5/pk) and LL Telescoping Cantilever Arms (5/pk) A Herbst Appliance is used to affect changes in the skeletaClass II · The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. | Device recalls |
| Mar 9, 2015 | Herbst Universal Nut which is used in a Herbst Appliance A Herbst Appliance is used to affect changes in the skeletal relationship and/or oClass II · The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. | Device recalls |
| Jan 27, 2009 | ACRYLIC HERBST SPLINT APPLIANCEK083209 · LRK | 510(k) clearances |
| Sep 25, 2007 | CLEAR IMAGE ALIGNERK071970 · NXC | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
