510(k) Report

510(k) · Cleared

Cleared

Britesmile Masking Cream

K040797510(k) SpecialCleared Apr 2, 20044-day reviewClass I21 CFR 872.6300

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

Britesmile, Inc. · EIE Dam, Rubber

Cleared on Apr 2, 2004 as substantially equivalent to K010935 (Britesmile, Inc., 2001) after a 4-day review. Its family tree reaches back 1 generation to 2001.

Decided
Apr 2, 2004
Review
4 days
Class
Class I
Product code
EIE
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K010935 (2001). No later device cites it as a predicate yet.

K010935 · Britesmile Barrier Material · Britesmile, Inc. · 20012000200220042006
K010935 · Britesmile Barrier Material · Britesmile, Inc. · 20010
  1. Root · 1 generation backK010935 Britesmile Barrier MaterialBritesmile, Inc. · 2001
  2. This deviceK040797 Britesmile Masking CreamBritesmile, Inc. · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K010935Britesmile Barrier MaterialBritesmile, Inc.2001—
0 (this device)K040797Britesmile Masking CreamBritesmile, Inc.2004—
FIG. 1 — Lineage of K040797, 2001–2004Source: 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 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in EIE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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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
*K010935Britesmile Barrier Material
Summary page 1
…n Common/Usual Name: Gingival isolation material Classification Name: Rubber Dam 3. PREDICATE DEVICE BriteSmile Barrier Material, K010935 4. INTENDED USE The BriteSrnile Masking, Cream is intended to be used as an accessory to the BriteS…
Britesmile, Inc.2001—

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.

How does its category compare?

All EIE devices

EIE Dam, Rubber: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EIE

1in 2019

2016: 12019: 1
2007high 1 (2016) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EIE

Too few EIE 510(k)s in any year since 2007 to give a median.

Recalls per year · EIE

No recall names EIE since 2007.

Adverse event reports per year · EIE

1in 2024

2009: 12010: 12012: 12013: 12015: 22016: 12017: 22018: 42019: 22021: 22022: 12024: 1
2007high 4 (2018) · low 0 (2007)2025

MAUDE reports naming product code EIE, 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
20070—00
20080—00
20090—01
20100—01
20110—00
20120—01
20130—01
20140—00
20150—02
20161—01
20170—02
20180—04
20191—02
20200—00
20210—02
20220—01
20230—00
20240—01
20250—00
20260—0—

What is it indicated for?

The BriteSmile Masking Cream is intended to be used as an accessory to the BriteSmile Barrier Material to protect soft tissues during teeth-whitening procedures.

Indications for use as stated in the FDA 510(k) statement.

More from Britesmile, Inc.

2 FDA decisions under this applicant name. See the company

  • K010935Britesmile Barrier MaterialBritesmile, Inc. · 2001

Recent decisions in EIE

The EIE category page

  • K182118armor LCMavrik Dental Systems, Ltd. · 2019
  • K151945Triumph Resin DamDenali Corporation · 2016
  • K050318Bari-Kad Packing DeviceBioenvelop Agro, Inc. · 2005
  • K043301GC Tion Gingival ProtectorGC America, Inc. · 2005
  • K022522Pulpdent Putty DamPulpdent Corporation · 2002

https://510kreport.com/device/K040797 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040797: Britesmile Masking Cream.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040797

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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