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FDA product code · Dental · Class 1

EIA: Unit, Operative Dental

EIA is FDA's product code for "Unit, Operative Dental": a Class 1 device classified under 21 CFR 872.6640, reviewed by the Dental panel.

510(k) review time for EIA

Across 22 510(k) clearances under EIA decided from 2018-01-01 to 2026-10-06, the median was 270 days from FDA receipt to decision. Half took between 196 and 414 days, and 80% were decided within 480 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, EIA, decisions 2018-01-01 to 2026-10-06 (n = 22)
Fastest0
25th percentile196
Median270
75th percentile414
80th percentile480
90th percentile663
Slowest947

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.

EIA in the public FDA record

Records naming EIA, from openFDA (snapshot of 2026-09-15)
510(k) clearances, all years285
Establishment listings158
GUDID device identifiers1,567

Counts of records, not of devices or events. Adverse event reports for EIA are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.

FDA-recognized standards that cite EIA

14 FDA recognized consensus standards cite EIA, 3 of them recognized only in part, among them ISO 9168 Third edition 2009-07-15; ISO 7494-1 Third edition 2018-06; ISO 7405 Third edition 2018-10 Corrected version 2018-12. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.

  • 4-180 ISO 9168 Third edition 2009-07-15 — Dentistry - Hose connectors for air driven dental handpieces
  • 4-250 ISO 7494-1 Third edition 2018-06 — Dentistry - Stationary dental units and dental patient chairs - Part 1: General requirements
  • 4-261 ISO 7405 Third edition 2018-10 Corrected version 2018-12 — Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
  • 4-262 IEC 80601-2-60 Edition 2.0 2019-06 — Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
  • 4-269 ISO 3964 Third edition 11-2016 — Dentistry - Coupling dimensions for handpiece connectors [Including AMENDMENT 1 (2018)]
  • 4-276 ISO 14457 Second edition 2017-10 (partial recognition) — Dentistry - Handpieces and motors
  • 4-281 ISO 1797 Third Edition 2017-05 — Dentistry - Shanks for rotary and oscillating instruments
  • 4-305 ISO 10637 Second edition 2018-05 (partial recognition) — Dentistry - Central suction source equipment
  • 4-306 ISO 22052 First edition 2020-06 (partial recognition) — Dentistry - Compressed air source equipment
  • 4-314 ISO 7494-2 Third edition 2022-07 — Dentistry - Stationary dental units and dental patient chairs - Part 2: Air water suction and wastewater systems
  • 4-317 ISO 8325 Third edition 2023-03 — Dentistry - Test methods for rotary instruments
  • 4-334 ISO 11143 Second edition 2008-07 — Dentistry - Amalgam separators
  • 4-341 ANSI ADA Standard No. 47-1-2021 — Stationary Dental Units and Patient Chairs-Part 1: General Requirements
  • 4-342 ANSI ADA Standard No. 47-2-2021 — Stationary Dental Units and Patient Chairs-Part 2: Air Water Suction and Wastewater Systems

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

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