510(k) Report

510(k) · Cleared

Cleared

Niveous Liquid Dam

K021613510(k) TraditionalCleared Jun 20, 200235-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

Shofu Dental Corp. · EIE Dam, Rubber

Cleared on Jun 20, 2002 as substantially equivalent to K972775 (Interdent, Inc., 1998) and 1 other predicate after a 35-day review. Its family tree reaches back 1 generation to 1997.

Decided
Jun 20, 2002
Review
35 days
Class
Class I
Product code
EIE
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K971284 (1997). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1998: 1 other ancestorK971284 · Opaldam · Ultradent Products, Inc. · 199719961998200020022004
Other ancestors, by generation 1 generation back: 1 other ancestor K971284 · Opaldam · Ultradent Products, Inc. · 19970
  1. Root · 1 generation backK971284 OpaldamUltradent Products, Inc. · 1997
  2. This deviceK021613 Niveous Liquid DamShofu Dental Corp. · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K971284OpaldamUltradent Products, Inc.1997—
0 (this device)K021613Niveous Liquid DamShofu Dental Corp.2002—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
FIG. 1 — Lineage of K021613, 1997–2002Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 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
Get a 510(k) Report

What was it cleared against? (2)

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
*K972775Fastdam
Summary page 2
…Niveous Liquid Dam is similar in use and formulation to other dental dams that have been on the market for several years. (Interdent Incorporated, FastDam 5lO(k) K972775, among others) The formulation does not contain any new or non-conventional chemicals; therefore, new biocompatibility testin…
Interdent, Inc.1998—
*K971284Opaldam
Summary page 1
…872.6300 Substantially Equivalent Devices FastDam [51O(k) Number - Kg727751 OpalDam [51O(k) Number - K9712841 Description of Niveous Liquid Dam Niveous Liquid Dam is a light-cured resin used for soft tissue isolation/protection during…
Ultradent Products, Inc.1997—

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?

  • None of the 2 ancestors has a 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 Niveous Liquid Dam resin is indicated to protect soft tissue during in-office

bleaching.

Indications for use as stated in the FDA summary.

More from Shofu Dental Corp.

59 FDA decisions under this applicant name. See the company

  • K111855HY-Bond ResiglassShofu Dental Corp. · 2011
  • K110235Beautibond MultiShofu Dental Corp. · 2011
  • K110252Beautibond Multi PR PlusShofu Dental Corp. · 2011
  • K101621Lite ArtShofu Dental Corp. · 2010
  • K101603Beautifil Flow PlusShofu Dental Corp. · 2010

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
  • K040797Britesmile Masking CreamBritesmile, Inc. · 2004

https://510kreport.com/device/K021613 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021613: Niveous Liquid Dam.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021613

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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