Product code EIA— Dental
A-DEC SELF-CONTAINED WATER SYSTEM
- Classification name
- Unit, Operative Dental
- Device class
- Class 1
- Regulation
- 21 CFR 872.6640
- Advisory panel
- Dental
- Total cleared
- 285
- First cleared
- Most recent
Market context for product code EIA
FDA has cleared devices under product code EIA between 1977 and 2026, filed by 194 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
last 15 years- 2026
- 2025
- 2024
- 2023
- 2022
- 2020
- 2019
- 2018
- 2017
- 2016
- 2015
- 2014
- 2013
- 2012
- 2011
Top applicants under product code EIA
Recent clearances under product code EIA
1–100 of 285- K251544 — Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)
- K251626 — Midmark Dental Delivery System
- K251491 — K5 Cart, K5 Mount, K5 Swing
- K243130 — Integral Dental Unit
- K242611 — Integral Dental Units
- K250473 — Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus
- K242404 — BDC Dental Unit
- K231297 — Firstar Dental Unit
- K233805 — K5
- K240754 — N2
- K231845 — Dental unit Model: Mare
- K202963 — ELEC Master, ELEC Master Dual
- K211556 — N2
- K213749 — G7, Dental Operative Unit and Accessories
- K220873 — Perceptive electric dental motor and control unit
- K213742 — Infinity Pro, Logic, Quality, Sprint
- K213932 — A-dec 300, A-dec 500
- K180935 — Infinity / Infinity Cross Flex Dental Systems
- K183347 — K3
- K183121 — Qraypen
- K173608 — Forest Dental Unit
- K171872 — P50 Series Dental Operative Unit and Accessories
- K152830 — K3
- K161734 — Vanguard Dental Unit
- K161488 — ESTETICA Dental Treatment Unit and Accessories
- K151996 — TAURUS C1
- K152100 — Evogue Dental Unit
- K143696 — Spirit
- K151045 — TENEO Dental Treatment Unit and Accessories
- K150909 — INTEGO Family and Accesories
- K150490 — UnicLine Mobile
- K142206 — Dental Unit
- K141504 — T-8000 THEROZONE UNIT
- K133412 — S200, S300
- K132245 — AJAX DENTAL UNIT
- K132315 — ERGONOMIC PRODUCTS WORKSTATION
- K130534 — DIPLOMAT
- K130410 — DENTAL UNIT WITH CHAIR
- K120239 — ELEVANCE
- K110481 — TRITON SELF CONTAINED DENTAL SYSTEM, TRITON SELF CONTAINED DENTAL SYSTEM, WITH CASE
- K111907 — DYNAMIC DU SERIES PORTABLE DENTAL UNIT
- K112321 — CS 1200
- K101332 — AMC-20 PORTABLE DENTAL CART MODEL AMC-20
- K102223 — CHALLENGE-EVER
- K103550 — YOBOSHI DENTAL UNIT
- K102234 — A-DEC 200 DENTAL SYSTEM
- K100212 — DENTACENTER/EXPEDITION, MODEL SAF-430
- K092917 — STERN'S S250 NORDAM
- K092851 — MODEL GDCH-2000
- K091186 — KODAK 1500 INTRAORAL CAMERA
- K090079 — VIVID, MODELS 40-A0001, 40-A0004, 40-A0006
- K082985 — A-DEC 334/335 DELIVERY SYSTEM
- K081699 — PLANMECA SOVEREIGN
- K081237 — CRAFTMASTER CONTOUR EQUIPMENT, INC., VISTA MODEL V-20, SATELLITE MOBILE UNIT MODEL ST-98 AND SATELLITE UNIT
- K082294 — WESTAR SERIES DENTAL UNITS
- K080677 — COMFORTRONIC 4894 AND COMFORTDRIVE 200XDA HANDPIECE
- K080438 — DENTAL UNIT WITH CHAIR
- K071485 — TPC ADVANCECAM INTRA ORAL CAMERA SYSTEM, MODEL AIC 888
- K063646 — OPTI
- K070196 — FLIGHT DENTAL SYSTEMS A-SERIES DENTAL OPERATIVE UNIT
- K062897 — C-U2
- K063302 — SDIF DENTAL CHAIR WITH OPERATIVE UNIT AND ACCESSORIES
- K052574 — COMPACT PLUS - EXTREME - PERFECT PLUS
- K061175 — CLARIS I310D INTRAORAL CAMERA SYSTEM & ACCESSORIES
- K050571 — ABSOLUTE AMERICA
- K052470 — F1 SERIES DENTAL CHAIRS WITH OPERATIVE UNIT
- K051657 — A-DEC SELF-CONTAINED WATER SYSTEM
- K050201 — AEU-14CF EXPENDITION
- K043496 — SPACELINE EMCIA, MODEL CU580
- K043325 — ZOOMCAM LD-10 INTRAORAL CAMERA AND ACCESSORIES
- K042759 — OPTIMA MX
- K041805 — MICROSCOPE SYSTEM
- K041458 — MARE DENTAL OPERATIVE UNIT
- K040529 — COCOON HYGIENIST
- K040117 — UNIPORT SELF-CONTAINED PORTABLE DENTAL UNIT
- K040116 — HAWK INTRAORAL CAMERA AND ACCESSORIES
- K033925 — BIOFREE
- K040691 — INTRA ORAL CAMERA SYSTEM & ACCESSORIES, MODEL WIN-100D
- K033419 — STV PRO 2
- K032757 — A-DEC SELF-CONTAINED WATER SYSTEM, MODEL 0.7 LITER BOTTLE & 2 LITER BOTTLE
- K032756 — A-DEC 532/533 DELIVERY SYSTEM MODEL, 532/533
- K032543 — SIRONA DENTAL SYSTEMS C8+DENTAL OPERATIVE UNIT WITH ACCESSORIES
- K031681 — STERISIL ANTIMICROBIAL TUBING AND BOTTLE
- K032904 — ACUCAM CONCEPT IV FWT, MODEL 110-0185G1
- K032070 — ELCACAM
- K032341 — INTRA ORAL CAMERA SYSTEM AND ACCESSORIES, MODEL CLARIS I310
- K023815 — C-1805M
- K023896 — C-1890
- K023513 — LOGOS JUNIOR DENTAL CHAIR AND UNIT
- K023213 — RDH-2000
- K022217 — AEU-425 TRANSPORT II PORTABLE DENTAL SYSTEM
- K021083 — VERACAM
- K020833 — BOYD DELIVERY UNIT
- K020957 — ORACAM
- K020206 — INTRAORAL CAMERA ME-15
- K013690 — IDENT-A100 INTRAORAL VIDEO CAMERA
- K012744 — INTRAORAL LENS OPTION TO SPECTROSHADE
- K012505 — SOPRO595 INTRA ORAL CAMERA
- K012213 — GULLIVER AND CLASSE A
- K011222 — PORTABELL, MODEL 4200
Data sourced from openFDA. This site is unofficial and independent of the FDA.