510(k) Report

510(k) · Cleared

Cleared

Conform

K062157510(k) TraditionalCleared Oct 13, 200677-day reviewClass II21 CFR 872.3690

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Apex Dental Materials, Inc. · EBF Material, Tooth Shade, Resin

Cleared on Oct 13, 2006 as substantially equivalent to K955292 (Bisco, Inc., 1995) after a 77-day review. Its family tree reaches back 1 generation to 1995.

Decided
Oct 13, 2006
Review
77 days
Class
Class II
Product code
EBF
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K955292 (1995). No later device cites it as a predicate yet.

Reference device: K974413 · Permaflo · Ultradent Products, Inc. · 1998 · recalledK955292 · Aeliteflo · Bisco, Inc. · 19951996199820002002200420062008
K955292 · Aeliteflo · Bisco, Inc. · 19950
  1. Root · 1 generation backK955292 AelitefloBisco, Inc. · 1995
  2. This deviceK062157 ConformApex Dental Materials, Inc. · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K955292AelitefloBisco, Inc.1995—
0 (this device)K062157ConformApex Dental Materials, Inc.2006—
FIG. 1 — Lineage of K062157, 1995–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 EBF? 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 EBF device

  1. #1 K202846 Tera Harzscore 18.5 · 7 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K955292Aeliteflo
Summary page 1
…on: Regulatory Class: 2 Product Code: EBF IDENTIFICATION OF THE LEGALLY MARKETED PREDICATE DEVICE PREDICATE DEVICE AELITEFLOV (Bisco, Inc. K955292) is a flowable composite material designed to act as a cavity filling or lining material. This system is applied directly to bon…
Bisco, Inc.1995—
†K974413PermafloUltradent Products, Inc.19981

Also cleared against K955292: 3 other devices →

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?

  • Its one ancestor has no recall.
  • 3 other devices also cite its predicate K955292.

How does its category compare?

All EBF devices

EBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EBF

15in 2025

2007: 192008: 142009: 202010: 192011: 192012: 112013: 132014: 102015: 172016: 202017: 152018: 152019: 172020: 152021: 132022: 172023: 92024: 182025: 152026 (partial year): 16
2007high 20 (2009) · low 9 (2023)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EBF

43in 2025

2007: 49 days median2008: 79 days median2009: 84 days median2010: 75 days median2011: 81 days median2012: 86 days median2013: 153 days median2014: 112 days median2015: 123 days median2016: 205 days median2017: 108 days median2018: 115 days median2019: 159 days median2020: 190 days median2021: 178 days median2022: 63 days median2023: 87 days median2024: 120 days median2025: 43 days median2026 (partial year): 59 days median
2007high 205 (2016) · low 43 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · EBF

1in 2020

2007: 12008: 422009: 12010: 62011: 72017: 42019: 22020: 12026 (partial year): 2
2007high 42 (2008) · low 0 (2012)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · EBF

1in 2025

2007: 62008: 102009: 82010: 312011: 312012: 622013: 2462014: 1952015: 1192016: 1432017: 422018: 82019: 112020: 22021: 22022: 22023: 82024: 52025: 1
2007high 246 (2013) · low 1 (2025)2025

MAUDE reports naming product code EBF, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007194916
200814794210
2009208418
20101975631
20111981731
20121186062
2013131530246
2014101120195
2015171230119
2016202050143
201715108442
20181511508
201917159211
20201519012
20211317802
2022176302
202398708
20241812005
2025154301
202616592—

What is it indicated for?

CONFORMTM is a light cured (free radical polymerization), flowable composite material, designed for use as a filling material for small restorations, a sealant material for occlusal surfaces, or a lining material in the base of large restorations. CONFORMTM is a versatile composite material which, when utilized properly, provides a strong, wear resistant material for dental restorations. CONFORMTM can also be used as the initial filled layer or liner of…

Read the full statement (110 words)

CONFORMTM is a light cured (free radical polymerization), flowable composite material, designed for use as a filling material for small restorations, a sealant material for occlusal surfaces, or a lining material in the base of large restorations.

CONFORMTM is a versatile composite material which, when utilized properly, provides a strong, wear resistant material for dental restorations. CONFORMTM can also be used as the initial filled layer or liner of a cavity restoration. When used as a liner, the material provides a strong base that assures the mechanical interface between the bonded tooth substrate and a highly filled composite are optimal. CONFORMTM is compatible with all other methacrylate based dental materials.

Indications for use as stated in the FDA summary.

Also cleared against K955292

3 other devices cite the same predicate.

  • K031341Stick FlowStick Tech, Ltd. · 2003
  • K982395Dytract Flow RestorativeDentsply Intl. · 1998
  • K981965Flowable CompositeDentsply Intl. · 1998

More from Apex Dental Materials, Inc.

15 FDA decisions under this applicant name. See the company

  • K190998BA Pit & Fissure SealantApex Dental Materials, Inc. · 2019
  • K161077RnD TE and RnD SEApex Dental Materials, Inc. · 2017
  • K131043Apex Universal AdhesiveApex Dental Materials, Inc. · 2013
  • K131049ZRPApex Dental Materials, Inc. · 2013
  • K120620Clean and BoostApex Dental Materials, Inc. · 2012

Recent decisions in EBF

The EBF category page

  • K262982Core·it DualSpident Co., Ltd. · 2026
  • K262202Cerasmart ForteGC America, Inc. · 2026
  • K261695Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)Guilin Kevin Peter Technology Co., Ltd. · 2026
  • K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc. · 2026
  • K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc. · 2026

https://510kreport.com/device/K062157 · printed Nov 6, 2026

Cite this page

510(k) Report. “K062157: Conform.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062157

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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