HF-Etchant Hydrofluoric Acid Etching Gel

HF-Etchant Hydrofluoric Acid Etching Gel is a hydrofluoric acid-based etching agent delivered in a syringe with a disposable tip. It is used for extraoral etching of porcelain and ceramic restorations (veneers, crowns, and inlays) to condition the surface prior to bonding and cementation procedures.

The subject device is composed of water, hydrofluoric acid, thickening agent, and pigment in gel form, identical to the predicate. Both are water-soluble, in-vitro etching agents delivered as prescription syringes. Minor differences exist: the subject device's application time is 10–60 seconds versus the predicate's 20–40 seconds; however, both condition porcelain/ceramic surfaces and share equivalent physical properties including thermostability, acid content, viscosity, and pH.

ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process) was cited to support the determination that biocompatibility testing is not required because the device does not contact the patient's body directly or indirectly.

The subject device is substantially equivalent to the predicate (Liaoning Upcera Ceramic Etchant, K240153) because both have identical composition (water, hydrofluoric acid, thickener, pigment), the same intended use (extraoral etching of porcelain/ceramic restorations), equivalent clinical performance (in-vitro surface conditioning), identical physical form (gel) and delivery mechanism (syringe), and the same regulatory classification as prescription devices. The predicate has been legally marketed with no reported clinical adverse events. The minor difference in application time (10–60 versus 20–40 seconds) does not affect intended use or safety, and stability testing confirms the subject device maintains appropriate physical properties within a 2-year shelf life.