510(k) · Cleared
ClearedRapicure 200 (Curing and Whitening Light)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mediphotonix, LC · EBZ Activator, Ultraviolet, For Polymerization
Cleared on Nov 1, 1999 as substantially equivalent to K952333 (American Dental Technologies, Inc., 1995) and 5 other predicates after a 35-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Nov 1, 1999
- Review
- 35 days
- Class
- Class II
- Product code
- EBZ
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 2 generations to K951425 (1995). 7 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K951425 | Spectrum Curing Light Polymerization Unit | Dentsply Intl. | 1995 | — |
| −1 | K982318 | Spectrum 800 Curing Unit | Dentsply Intl. | 1998 | — |
| 0 (this device) | K993223 | Rapicure 200 (Curing and Whitening Light) | Mediphotonix, LC | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1998 | 4 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EBZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new EBZ device
- #1 K253131 Curing Light (M-Cure 6)score 12.7 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K952333 | Plasma Arc Curing SystemSummary page 1…bstantial Equivalence: RapiCure 2000™ Curing and Whitening Light is substantially equivalent to the Plasma Arc Curing system cleared by American Dental Technologies in K-952333, to the Apollo 95 curing and whitening system cleared in K-981948 by Dental/Medical Diagnostic Systems, Inc., to the Ardent Radia… | 1995 |
| * | K981948 | Apollo 95ESummary page 1…s substantially equivalent to the Plasma Arc Curing system cleared by American Dental Technologies in K-952333, to the Apollo 95 curing and whitening system cleared in K-981948 by Dental/Medical Diagnostic Systems, Inc., to the Ardent Radiance Curing Light cleared by Air Techniques, Inc., in K-982615, to… | 1998 |
| * | K982615 | Airdent Radiance Curing LightSummary page 1…95 curing and whitening system cleared in K-981948 by Dental/Medical Diagnostic Systems, Inc., to the Ardent Radiance Curing Light cleared by Air Techniques, Inc., in K-982615, to the Spectrum 800 Curing Unit, cleared by Dentsply in K-982318, the CU-100A Light Cure Unit cleared in K-980792, the O-Luxpro… | 1998 |
| * | K982318 | Spectrum 800 Curing UnitSummary page 1…cal Diagnostic Systems, Inc., to the Ardent Radiance Curing Light cleared by Air Techniques, Inc., in K-982615, to the Spectrum 800 Curing Unit, cleared by Dentsply in K-982318, the CU-100A Light Cure Unit cleared in K-980792, the O-Luxpro V/Q-Luxpro Il Light Unit cleared in K-980793 and several other cur… | 1998 |
| * | K980792 | CU-100A Light Cure UnitSummary page 1…nce Curing Light cleared by Air Techniques, Inc., in K-982615, to the Spectrum 800 Curing Unit, cleared by Dentsply in K-982318, the CU-100A Light Cure Unit cleared in K-980792, the O-Luxpro V/Q-Luxpro Il Light Unit cleared in K-980793 and several other curing lights cleared under code EBF as accessories… | 1998 |
| * | K980793 | Q-Luxpro V/Q-Luxpro II Light Cure UnitSummary page 1…15, to the Spectrum 800 Curing Unit, cleared by Dentsply in K-982318, the CU-100A Light Cure Unit cleared in K-980792, the O-Luxpro V/Q-Luxpro Il Light Unit cleared in K-980793 and several other curing lights cleared under code EBF as accessories to composite materials classified as "tooth-shade resin and… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 3.4 years on median.
- None of the 7 ancestors has a recall.
- 2 other devices also cite its predicate K952333.
How does its category compare?
All EBZ devicesEBZ Activator, Ultraviolet, For Polymerization: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EBZ
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBZ
105in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBZ
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBZ
1in 2025
MAUDE reports naming product code EBZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 10 | 47 | 0 | 1 |
| 2008 | 5 | 75 | 0 | 7 |
| 2009 | 4 | 69 | 0 | 5 |
| 2010 | 1 | — | 0 | 5 |
| 2011 | 3 | 137 | 0 | 18 |
| 2012 | 1 | — | 1 | 20 |
| 2013 | 3 | 171 | 0 | 27 |
| 2014 | 3 | 289 | 0 | 31 |
| 2015 | 4 | 252 | 0 | 8 |
| 2016 | 4 | 251 | 0 | 3 |
| 2017 | 8 | 158 | 0 | 5 |
| 2018 | 2 | — | 1 | 3 |
| 2019 | 5 | 145 | 0 | 0 |
| 2020 | 5 | 164 | 0 | 2 |
| 2021 | 1 | — | 0 | 4 |
| 2022 | 5 | 144 | 1 | 5 |
| 2023 | 3 | 255 | 0 | 7 |
| 2024 | 1 | — | 0 | 3 |
| 2025 | 4 | 105 | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
This device is intended for use:
1. As a source of illumination for curing dental restorative materials,
2. Assisting in the whitening process in a dental office.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993223 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993223: Rapicure 200 (Curing and Whitening Light).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993223
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026