K252942
Substantially EquivalentShaeferH
ShaeferH is a dental appliance — product code LRK covers preformed orthodontic or mouthguard-style appliances, typically fabricated from thermoplastic materials. The device_name is generic and the filing provides little additional context on the specific indication.
Dental panel, Traditional 510(k). Shaeferh LLC is a small-applicant filer (single-name product, single-applicant LLC based in Boston) — LRK sees regular traffic from small dental-device companies because the predicate set is well-established and substantial equivalence arguments on this code tend to be straightforward.
Seven-month review clock. The short product name and thin filing metadata are common for LRK submissions at this scale.
- Applicant
- Shaeferh, LLC
- Product code
- LRK
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boston, MA, US
Adverse events under product code LRK
product code LRK- Injury
- 246
- Malfunction
- 1,044
- Total
- 1,290
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.