510(k) Report

510(k) · Cleared

Cleared

Adhere Conditioner, Adhere Primer, Adhere LC Adhesive, Adhere DC Adhere DC Activator, Adhere Cylanate

K992838510(k) TraditionalCleared Nov 15, 199984-day reviewClass II21 CFR 872.3200

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

Biomat Sciences, Inc. · KLE Agent, Tooth Bonding, Resin

Cleared on Nov 15, 1999 as substantially equivalent to K923546 (Kerr Corporation (Danbury), 1992) and 3 other predicates after an 84-day review. Its family tree reaches back 1 generation to 1990.

Decided
Nov 15, 1999
Review
84 days
Class
Class II
Product code
KLE
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K896659 (1990). 4 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1995: 1 other ancestor1992: 1 other ancestor1991: 1 other ancestorK896659 · Silane · Pulpdent Corp. · 1990199019921994199619982000
Other ancestors, by generation 1 generation back: 3 other ancestors K896659 · Silane · Pulpdent Corp. · 19900
  1. Root · 1 generation backK896659 SilanePulpdent Corp. · 1990
  2. This deviceK992838 Adhere Conditioner, Adhere Primer, Adhere LC Adhesive, Adhere DC…Biomat Sciences, Inc. · 1999
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K896659SilanePulpdent Corp.1990—
0 (this device)K992838Adhere Conditioner, Adhere Primer, Adhere LC Adhesive, Adhere DC Adhere DC…Biomat Sciences, Inc.1999—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199210
199510
FIG. 1 — Lineage of K992838, 1990–1999Source: 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 KLE? 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 KLE device

  1. #1 K262252 MPa Max adhesivescore 15.1 · 11 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? (4)

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
*K923546Optibond
Summary page 1
…ent, tooth bonding, resin (per CFR 872.3200) 3. Legally marketed device for which substantial equivalence is being claimed 4. Device Description Optibond (Kerr, 510k #K923546) All Bond 2 (Bisco, 510k #K910860) One Step (Bisco, 510k #K945604) Silane Bond Enhancer (Pulpdent Corporation 510k #896659) A…
Kerr Corporation (Danbury)1992—
*K910860All-Bond 2
Summary page 1
…872.3200) 3. Legally marketed device for which substantial equivalence is being claimed 4. Device Description Optibond (Kerr, 510k #K923546) All Bond 2 (Bisco, 510k #K910860) One Step (Bisco, 510k #K945604) Silane Bond Enhancer (Pulpdent Corporation 510k #896659) Adhere is an adhesive system used fo…
Bisco, Inc.1991—
*K945604Ecliptomer
Summary page 1
…vice for which substantial equivalence is being claimed 4. Device Description Optibond (Kerr, 510k #K923546) All Bond 2 (Bisco, 510k #K910860) One Step (Bisco, 510k #K945604) Silane Bond Enhancer (Pulpdent Corporation 510k #896659) Adhere is an adhesive system used for the bonding of directly and ind…
Bisco, Inc.1995—
*K896659Silane
Summary page 1
…Device Description Optibond (Kerr, 510k #K923546) All Bond 2 (Bisco, 510k #K910860) One Step (Bisco, 510k #K945604) Silane Bond Enhancer (Pulpdent Corporation 510k #896659) Adhere is an adhesive system used for the bonding of directly and indirectly placed restorative materials to tooth structure. I…
Pulpdent Corp.1990—

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 4 ancestors has a recall.

How does its category compare?

All KLE devices

KLE Agent, Tooth Bonding, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KLE

3in 2025

2007: 142008: 32009: 72010: 82011: 102012: 52013: 112014: 62015: 102016: 32017: 42018: 82019: 62020: 62021: 42022: 82023: 62024: 72025: 32026 (partial year): 7
2007high 14 (2007) · low 3 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KLE

149in 2025

2007: 71 days median2008: 66 days median2009: 79 days median2010: 93 days median2011: 100 days median2012: 66 days median2013: 115 days median2014: 120 days median2015: 118 days median2016: 148 days median2017: 171 days median2018: 124 days median2019: 143 days median2020: 195 days median2021: 163 days median2022: 98 days median2023: 75 days median2024: 61 days median2025: 149 days median2026 (partial year): 84 days median
2007high 195 (2020) · low 61 (2024)2026

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

Recalls per year · KLE

1in 2024

2007: 22009: 12010: 12016: 12017: 12024: 1
2007high 2 (2007) · low 0 (2008)2026

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

Adverse event reports per year · KLE

3in 2025

2007: 182008: 92009: 112010: 132011: 692012: 1762013: 2482014: 2602015: 1002016: 472017: 422018: 312019: 202020: 62021: 62022: 72023: 72024: 122025: 3
2007high 260 (2014) · low 3 (2025)2025

MAUDE reports naming product code KLE, 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
20071471218
200836609
2009779111
2010893113
201110100069
20125660176
2013111150248
201461200260
2015101180100
20163148147
20174171142
20188124031
20196143020
2020619506
2021416306
202289807
202367507
2024761112
2025314903
20267840—

What is it indicated for?

to promote strong bonds to enamel and dentin for a) direct restorative materials such as composite resins, compomers, amalgam, and b) resins cements used in the bonding of indirect restorative materials, such as ceramic veneers, inlays, and crowns.

to seal dentinal tubules

to reduce sensitivity due to exposed tubules in abrasion/erosion lesions of teeth

to promote bonds between incremental layers of composite resins when building a composite restoration

to bond composite resins repairs to ceramics and metals

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Recent decisions in KLE

The KLE category page

  • K263680One Coat Bond; One Coat Bond SLDent4You AG · 2026
  • K262252MPa Max adhesiveDen-Mat Holdings, LLC · 2026
  • K260485Any-EtchMediclus Co., Ltd. · 2026
  • K260430Porcelain Etch GelBelport Company, Inc., Gingi-Pak · 2026
  • K252450Adhese 2Ivoclar Vivadent, Inc. · 2026

https://510kreport.com/device/K992838 · printed Nov 6, 2026

Cite this page

510(k) Report. “K992838: Adhere Conditioner, Adhere Primer, Adhere LC Adhesive, Adhere DC Adhere DC Activator, Adhere Cylanate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992838

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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