510(k) · Cleared
ClearedReso-Pac Periodontal Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hager Worldwide, Inc. · EMA Cement, Dental
Cleared on May 27, 2005 as substantially equivalent to K810545 (Pulpdent Corp. of America, 1981) and 2 other predicates after a 74-day review. Its family tree reaches back 1 generation to 1981. 4 later devices descend from it.
- Decided
- May 27, 2005
- Review
- 74 days
- Class
- Class II
- Product code
- EMA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K810545 (1981). 3 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK810545 Pca Periocare Periodontal DressingPulpdent Corp. of America · 1981
- This deviceK050658 Reso-Pac Periodontal DressingHager Worldwide, Inc. · 2005
- Descendant · cites it directly · 1 of its ownK083516 PeriogenixOroscience, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK071484 Periacryl 90,80,70,60, MODEL9010, 8020, 7030, 6040Glustitch, Inc. · 2007
- Descendant · 2 generations on · 0 of its ownK251908 Emanate TrayEmanate Biomedical · 2026
- Descendant · 2 generations on · 0 of its ownK142130 Oral BondSteiner Laboratories · 2016
Most influential descendants
Showing 4 of 4 · See all- K083516PeriogenixOroscience, Inc. · 2009 · cites it directly1descendant
- K071484Periacryl 90,80,70,60, MODEL9010, 8020, 7030, 6040Glustitch, Inc. · 2007 · cites it directly1descendant
- K251908Emanate TrayEmanate Biomedical · 2026 · 2 generations on0descendants
- K142130Oral BondSteiner Laboratories · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K810545 | Pca Periocare Periodontal Dressing | Pulpdent Corp. of America | 1981 | — |
| 0 (this device) | K050658 | Reso-Pac Periodontal Dressing | Hager Worldwide, Inc. | 2005 | — |
| +1 | K083516 | Periogenix | Oroscience, Inc. | 2009 | — |
| +1 | K071484 | Periacryl 90,80,70,60, MODEL9010, 8020, 7030, 6040 | Glustitch, Inc. | 2007 | — |
| +2 | K251908 | Emanate Tray | Emanate Biomedical | 2026 | — |
| +2 | K142130 | Oral Bond | Steiner Laboratories | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2016 | 1 | 0 |
| 2026 | 1 | 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 EMA? 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 EMA device
- #1 K254109 G-Cem Universalscore 15.0 · 13 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K810545 | Pca Periocare Periodontal DressingSummary page 1…al for marketing in the European Community. It is substantially equivalent to other periodontal dressings, including PCA Periocare Periodontal Dressing (Pulpdent Corp. - K810545), Coe Pak (Coe Laboratories - K881422) and Barricaid (Dentsply International - K864720), which are intended to protect injured pe… | 1981 |
| * | K881422 | Coe Pak Auto Mix, Regular or Hard SetSummary page 1…nity. It is substantially equivalent to other periodontal dressings, including PCA Periocare Periodontal Dressing (Pulpdent Corp. - K810545), Coe Pak (Coe Laboratories - K881422) and Barricaid (Dentsply International - K864720), which are intended to protect injured periodontal tissue by forming… | 1988 |
| * | K864720 | Light-Cured Periodontal DressingSummary page 1…iodontal dressings, including PCA Periocare Periodontal Dressing (Pulpdent Corp. - K810545), Coe Pak (Coe Laboratories - K881422) and Barricaid (Dentsply International - K864720), which are intended to protect injured periodontal tissue by forming… | 1987 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 3 ancestors has a recall.
- Of its descendants, K083516 (Oroscience, Inc., 2009) has gone furthest, with 1 descendant of its own.
How does its category compare?
All EMA devicesEMA Cement, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EMA
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EMA
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EMA
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EMA
9in 2025
MAUDE reports naming product code EMA, 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 | 6 | 48 | 0 | 33 |
| 2008 | 13 | 71 | 2 | 50 |
| 2009 | 10 | 86 | 1 | 90 |
| 2010 | 14 | 86 | 1 | 106 |
| 2011 | 8 | 79 | 5 | 224 |
| 2012 | 10 | 128 | 0 | 249 |
| 2013 | 12 | 178 | 0 | 385 |
| 2014 | 4 | 174 | 0 | 207 |
| 2015 | 9 | 134 | 0 | 85 |
| 2016 | 10 | 182 | 0 | 16 |
| 2017 | 3 | 141 | 0 | 13 |
| 2018 | 3 | 237 | 0 | 4 |
| 2019 | 7 | 127 | 0 | 12 |
| 2020 | 8 | 164 | 0 | 5 |
| 2021 | 4 | 184 | 0 | 8 |
| 2022 | 7 | 245 | 0 | 3 |
| 2023 | 2 | — | 1 | 6 |
| 2024 | 3 | 59 | 0 | 5 |
| 2025 | 10 | 106 | 0 | 9 |
| 2026 | 7 | 150 | 0 | — |
What is it indicated for?
For use as a periodontal wound dressing to protect injured periodontal tissue by forming a barrier to avoid further irritation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050658 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050658: Reso-Pac Periodontal Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050658
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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