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FDA product code · Dental · Class 2

NVK: Laser, Dental, Soft Tissue

NVK is FDA's product code for "Laser, Dental, Soft Tissue": a Class 2 device classified under 21 CFR 878.4810, reviewed by the Dental panel.

510(k) review time for NVK

Across 16 510(k) clearances under NVK decided from 2018-01-01 to 2026-10-06, the median was 191 days from FDA receipt to decision. Half took between 121 and 279 days, and 80% were decided within 283 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, NVK, decisions 2018-01-01 to 2026-10-06 (n = 16)
Fastest1
25th percentile121
Median191
75th percentile279
80th percentile283
90th percentile409
Slowest438

Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.

FDA-recognized standards that cite NVK

4 FDA recognized consensus standards cite NVK, among them ANSI IES RP-27.2-00/R17; IEC 62471 First edition 2006-07; ANSI IES RP-27.1-2015. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.

  • 12-102 ANSI IES RP-27.2-00/R17 — Recommended Practice for Photobiological Safety for Lamps and Lamp Systems - Measurement Techniques
  • 12-249 IEC 62471 First edition 2006-07 — Photobiological safety of lamps and lamp systems
  • 12-297 ANSI IES RP-27.1-2015 — Recommended Practice for Photobiological Safety for Lamps and Lamp Systems - General Requirements
  • 12-321 ANSI IES RP-27.3-17 — Recommended Practice for Photobiological Safety for Lamps - Risk Group Classification and Labeling

Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.

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