Are gels for fixing dentures considered medical devices?

Denture Fixation Gels are Medical Devices

Gels for fixing dentures are classified as medical devices (Answer A). 1

Regulatory Classification Framework

According to FDA regulations under Section 201(h) of the Federal Food, Drug & Cosmetic Act, a medical device is defined as any "instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article" that is:

• Intended to affect the structure or any function of the body 1
• Does not achieve its primary intended purposes through chemical action within or on the body 1
• Not dependent upon being metabolized for achievement of its primary intended purposes 1

Why Denture Adhesives Qualify as Medical Devices

Denture fixation gels meet all three criteria for medical device classification:

• They affect bodily structure and function by improving retention and stability of dentures, which directly impacts oral function including mastication and speech 2, 3
• They work through mechanical adhesion, not through chemical or metabolic action within the body 1
• Their primary mechanism is physical bonding between the denture and oral mucosa, creating a seal that enhances retention 2

European Union Classification

The EU Medical Device Regulation similarly classifies denture adhesives as medical devices, defining them as "any instrument, apparatus, appliance, software, material or other article" intended for "investigation, replacement or modification of the anatomy or of a physiological process" that does not achieve its principal action through pharmacological, immunological, or metabolic means 1

Clinical Evidence Supporting Device Classification

Research demonstrates that denture adhesives provide measurable functional benefits through mechanical means:

• Significantly improved retention and stability of well-fitting dentures using objective measurements (Kapur Index) 2
• Reduced denture dislodgements during functional activities like eating 2
• Enhanced patient confidence and comfort through improved denture performance 2, 3

Why Other Options Are Incorrect

• Not a medicinal product (B): Medicinal products achieve their effects through pharmacological, immunological, or metabolic action, which denture adhesives do not 1
• Not a cosmetic product (C): Cosmetic products are intended to beautify or alter appearance without affecting bodily function; denture adhesives directly affect oral function 1
• Not a disinfectant (D): Disinfectants are antimicrobial agents; denture adhesives provide mechanical retention without antimicrobial action 1

Practical Implications

Dental professionals should recognize that denture adhesives are legitimate therapeutic devices that can be prescribed as part of denture treatment and aftercare when clinically indicated 3. Custom-made dental devices including dentures themselves are also classified as medical devices and must be manufactured according to relevant medical device regulations 4, 5, 6.