PMA · Approved
ApprovedPeri-Oss
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Curasan AG · LPK (no longer in FDA’s product-code list)
Approved on Mar 24, 1981 through premarket approval, which rests on the device’s own clinical evidence after a 285-day review. 20 later devices descend from it.
- Decided
- Mar 24, 1981
- Review
- 285 days
- Class
- Class III
- Product code
- LPK
- Recalls
- None
20 later devices descend from it, 2 citing it directly.
- This deviceP800035 Peri-OssCurasan AG · 1981
- Descendant · cites it directly · 18 of its ownK051443 Cerasorb Dental, Cerasorb M Dental and Cerasorb PerioCurasan Ag, Frankfurt Facility · 2005
- Descendant · 2 generations on · 2 of its ownK053374 Ossaplast Dental (Particle Size of 500 to 1000 UM to 2000 UM)Ossacur AG · 2006
- Descendant · cites it directly · 2 of its ownK042583 Calc-I-OssUltradent Products, Inc. · 2005
- Descendant · 2 generations on · 1 of its ownK103709 Ceracell DentalCurasan AG · 2011
- Descendant · 2 generations on · 1 of its ownK090950 Bone Plus BCPMegagen Implant Co., Ltd. · 2010
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K051443Cerasorb Dental, Cerasorb M Dental and Cerasorb PerioCurasan Ag, Frankfurt Facility · 2005 · cites it directly18descendants
- K053374Ossaplast Dental (Particle Size of 500 to 1000 UM to 2000 UM)Ossacur AG · 2006 · 2 generations on2descendants
- K042583Calc-I-OssUltradent Products, Inc. · 2005 · cites it directly2descendants
- K103709Ceracell DentalCurasan AG · 2011 · 2 generations on1descendant
- K090950Bone Plus BCPMegagen Implant Co., Ltd. · 2010 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P800035 | Peri-Oss | Curasan AG | 1981 | — |
| +1 | K051443 | Cerasorb Dental, Cerasorb M Dental and Cerasorb Perio | Curasan Ag, Frankfurt Facility | 2005 | — |
| +2 | K053374 | Ossaplast Dental (Particle Size of 500 to 1000 UM to 2000 UM) | Ossacur AG | 2006 | — |
| +1 | K042583 | Calc-I-Oss | Ultradent Products, Inc. | 2005 | — |
| +2 | K103709 | Ceracell Dental | Curasan AG | 2011 | — |
| +2 | K090950 | Bone Plus BCP | Megagen Implant Co., Ltd. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 5 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LPK? 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
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it? (20)
See all 202 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?
- Of its descendants, K051443 (Curasan Ag, Frankfurt Facility, 2005) has gone furthest, with 18 descendants of its own.
https://510kreport.com/device/P800035 · printed Nov 4, 2026
Cite this page
510(k) Report. “P800035: Peri-Oss.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/P800035
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026