Professional-use dental products

Who may request clinical products

By requesting a quote for a product marked “Professional-use product,” the buyer confirms that they are a licensed professional or an authorized healthcare purchaser. Clinical products are not offered for patient self-treatment. The treating professional is responsible for patient selection, compatibility, sterilization, technique, and use.

Exact labeling controls

Use every product only according to its exact manufacturer label and instructions for use (IFU). The words “Rx Only,” FDA device class, clearance, exemption, indications, and warnings depend on the exact product. A website photo that does not show “Rx Only” is not enough to determine prescription status, and this catalog does not replace the label or IFU.

FDA class is not the same as consumer use

FDA’s generic classifications list dental burs under 21 CFR 872.3240 as Class I, air-powered dental handpieces under 21 CFR 872.4200 as Class I, endosseous dental implant abutments under 21 CFR 872.3630 as Class II, and synthetic bone-grafting materials under 21 CFR 872.3930 as Class II. Device class or 510(k) exemption alone does not mean a product is appropriate for home use.

Prescription labeling

Under 21 CFR 801.109, a prescription device is one that is not safe for use except under the supervision of a licensed practitioner and must bear the required prescription-device labeling, subject to the rule’s terms. Misieco does not call an exact item “FDA approved,” “FDA cleared,” or “Rx Only” unless the product’s own documentation supports that statement.

Official references

21 CFR 801.109 — Prescription devices
FDA classification: Dental bur (EJL)
FDA classification: Air-powered dental handpiece (EFB)
FDA classification: Endosseous implant abutment (NHA)
FDA classification: Synthetic bone-grafting material (LYC)

This policy describes Misieco’s sales practices and is not medical or legal advice. Contact the manufacturer or Misieco Sales if exact labeling is unclear.