PANTINO PRO POSITINER— 510(k) K102521
Substantially EquivalentSomnomed, Inc.
FDA 510(k) clearance K102521 for PANTINO PRO POSITINER, Substantially Equivalent on 2011-03-28. Applicant: Somnomed, Inc.. Device class: 2.
Clearance details
- Applicant
- Somnomed, Inc.
- Product code
- Code LRK
- Device class
- Class 2
- Regulation
- 21 CFR 872.5570
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Denton, TX, US
Recent devices under product code LRK
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view all- K233497 — Rest Assure System
- K183443 — SomnoDent Avant
- K162306 — SomnoDent ALPHA
- K150369 — SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac Micro-recorder, SomnoDent Herbst Advance (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent G2 (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent Fusion (Classic or Flex Retention) with DentiTrac Micro-recorder
- K140278 — SOMNODENT FUSION, CLASSIC; SOMNODENT FUSION, FLEX
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.