Once Bitten, Twice Shy: Recent FDA Warning Letter Takes Aim at DTC Dental Laboratory

A recent Warning Letter to a dental laboratory offering direct-to-consumer dental prosthetics highlights the ambiguous regulatory position occupied by dental laboratories and the products they produce for patients.  In June 2025, the dental laboratory Reset Technology Corporation received a Warning Letter identifying several areas of noncompliance with medical device regulations.  The violations identified in the letter made clear that FDA considered the dental laboratory to be engaged in device manufacturing activities and subject to the same regulatory requirements as manufacturers of other types of devices.

Historically, the traditional role of a dental laboratory has been “to manufacture prosthetics or devices in accordance with the written directives (or instructions) provided by a licensed dentist,” according to the American Dental Association.  Following Congressional enactment of the Medical Device Amendments of 1976, FDA promulgated regulations that exempted dental laboratories meeting certain criteria from registration and listing requirements in recognition of their distinct role.  21 C.F.R. Part 807 exempts:

[p]ersons who dispense devices to the ultimate consumer or whose major responsibility is to render a service necessary to provide the consumer (i.e., patient, physician, layman, etc.) with a device or the benefits to be derived from the use of a device; for example, a . . . dental laboratory . . . whose primary responsibility to the ultimate consumer is to dispense or provide a service through the use of a previously manufactured device.

21 C.F.R. § 807.65(i) (emphasis added).

The scope of the exemption as it pertains to dental laboratories has been a source of longstanding confusion.  Indeed, in responding to the Form FDA 483 that preceded the Warning Letter, Reset explained that it had previously registered as a device manufacturer “based on incorrect information from a regulatory consultant” but had since deactivated its registration with FDA for FY 2025.  Reset asserted that 21 C.F.R. § 807.65(i) applied because it “manufactures patient specific restorative devices (removable partial dentures) based upon a prescription from a licensed dentist” and “use[s] FDA cleared materials . . . to manufacture each patient specific device and do[es] not commercially distribute these devices.”  FDA disagreed, stating that Reset did not provide “a service through the use of previously manufactured devices” but rather “manufactures and distributes partial denture devices using devices that lack required approval/clearance and manufactures and distributes impression kits comprised of devices that lack required approval/clearance.“

The Warning Letter also cited numerous violations of the Quality System Regulation (QSR) requirements, including the failure to document procedures for process validation in connection with cleaning the partial denture device.  FDA rejected the dental laboratory’s assertion that process validations were not required since they had already been performed as part of the regulatory process for the FDA-cleared materials used in its devices.

Other QSR violations cited in the Warning Letter related to inadequate procedures for controlling non-conforming product, failure to establish and maintain procedures for rework, failure to adequately investigate complaints or maintain complaint files, and failure to adequately establish and maintain procedures for implementing corrective and preventive action.

FDA’s concerns appeared to be driven in part by the direct-to-consumer nature of the dental laboratory’s operations.  For example, the Warning Letter asserted that the “adjustment kits” provided to consumers at home to enable at-home modifications of their devices should have been reported as corrections pursuant to 21 C.F.R. Part 806, noting that ill-fitting dentures could lead to adverse health consequences.  The Warning Letter cited the dental laboratory’s failure to obtain premarket authorization for its devices and noted that the clearances cited by the dental laboratory were for different indications for use.  For example, the 510(k) cited by the dental laboratory for the impression material was for prescription use only, whereas the dental laboratory intended for the material “to be used by customers to take their own impression without the supervision of a dentist.”  This change “could significantly affect the safety and effectiveness of the impression material because customers who use at-home impression kits to take their own impressions may be more likely to take improper impressions—and improper impressions can lead to improper fabrication of the denture, which can cause bone loss/resorption, irritation, sores, and TMJ dysfunction.”

Additionally, the Warning Letter noted “it is unclear whether your firm is sending the impression material to customers with a prescription from a dentist—and the labeling of the impression kit does not appear to state that it is for prescription use only” and stated that “[c]hanging a device for prescription use only to a device for over the counter use also could significantly affect the safety or effectiveness of the device.”

The Warning Letter’s focus on a direct-to-consumer dental laboratory is consistent with concerns raised by the American Dental Association about the growing presence of direct-to-consumer dental laboratories, where patients are instructed to independently take their own impressions and order products without the involvement of a dentist.

Although the Warning Letter is specific to Reset Technology Corporation, other dental laboratories, in particular those incorporating direct-to-consumer practices, should take note and ensure they comply with applicable FDA regulations after careful consideration of whether their operations extend beyond what FDA considers to be a dental laboratory exempt from otherwise applicable regulations.