510(k) · Cleared
ClearedFriadent Cercon and Ankylos Cercon Balance Abutments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Intl. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Mar 27, 2008 as substantially equivalent to K980630 (Friatec AG, 1998) and 3 other predicates after a 183-day review. Its family tree reaches back 7 generations to 1990.
- Decided
- Mar 27, 2008
- Review
- 183 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K894595 (1990). 20 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 6 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 5 generations backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- 4 generations backK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
- 3 generations backK021318 Xive Dental Implant SystemFriadent GmbH · 2002
- 2 generations backK032158 Xive Dental Implant System MultipleFriadent GmbH · 2003
- 1 generation backK041509 Ankylos Dental Implant SystemFriadent GmbH · 2004
- This deviceK072730 Friadent Cercon and Ankylos Cercon Balance AbutmentsDentsply Intl. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −6 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −5 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| −4 | K013067 | Frialoc Dental Implant System | Friadent GmbH | 2002 | — |
| −3 | K021318 | Xive Dental Implant System | Friadent GmbH | 2002 | — |
| −2 | K032158 | Xive Dental Implant System Multiple | Friadent GmbH | 2003 | — |
| −1 | K041509 | Ankylos Dental Implant System | Friadent GmbH | 2004 | — |
| 0 (this device) | K072730 | Friadent Cercon and Ankylos Cercon Balance Abutments | Dentsply Intl. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 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 NHA? 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 NHA device
- #1 K222288 DESS Dental Smart Solutionsscore 30.6 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K980630 | Frialit-2 CorabaseSummary page 1…SIFICATION NAME: Endosseous dental implant abutment 872.3630 PREDICATE DEVICES: FRIALIT®-2 CeraBase Abutment K980630/K994376 ANKYLOS® Balance Abutment K012681/K041509 DEVICE DESCRIPTION:… | 1998 |
| * | K994376 | Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2 3.4MM Steeped…Summary page 1…ON NAME: Endosseous dental implant abutment 872.3630 PREDICATE DEVICES: FRIALIT®-2 CeraBase Abutment K980630/K994376 ANKYLOS® Balance Abutment K012681/K041509 DEVICE DESCRIPTION:… | 2000 |
| * | K012681 | AnkylosSummary page 1…EDICATE DEVICES: FRIALIT®-2 CeraBase Abutment K980630/K994376 ANKYLOS® Balance Abutment K012681/K041509 DEVICE DESCRIPTION: The CERCON® ABUTMENTS are part of the FRIADENT® prosthetics. The CERCON® ABUTMENTS… | 2003 |
| * | K041509 | Ankylos Dental Implant SystemSummary page 1…DEVICES: FRIALIT®-2 CeraBase Abutment K980630/K994376 ANKYLOS® Balance Abutment K012681/K041509 DEVICE DESCRIPTION: The CERCON® ABUTMENTS are part of the FRIADENT® prosthetics. The CERCON® ABUTMENTS are avai… | 2004 |
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?
- The line of descent spans 18 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 20 ancestors have a recall of any class.
- 2 other devices also cite its predicate K980630.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · NHA
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NHA
147in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NHA
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NHA
838in 2025
MAUDE reports naming product code NHA, 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 | 38 | 91 | 1 | 1 |
| 2008 | 31 | 90 | 2 | 8 |
| 2009 | 30 | 95 | 0 | 30 |
| 2010 | 19 | 162 | 0 | 61 |
| 2011 | 31 | 130 | 5 | 56 |
| 2012 | 25 | 171 | 1 | 5 |
| 2013 | 22 | 184 | 1 | 143 |
| 2014 | 27 | 160 | 0 | 146 |
| 2015 | 29 | 151 | 1 | 858 |
| 2016 | 38 | 202 | 36 | 314 |
| 2017 | 31 | 188 | 2 | 577 |
| 2018 | 31 | 200 | 1 | 591 |
| 2019 | 28 | 160 | 0 | 530 |
| 2020 | 38 | 153 | 7 | 458 |
| 2021 | 29 | 211 | 0 | 546 |
| 2022 | 33 | 142 | 0 | 497 |
| 2023 | 51 | 147 | 3 | 618 |
| 2024 | 43 | 158 | 0 | 635 |
| 2025 | 40 | 147 | 1 | 838 |
| 2026 | 23 | 169 | 3 | — |
What is it indicated for?
The FRIADENT® CERCON® Abutment is indicated for the support of exceptionally esthetic,
single crowns in the anterior region of the maxilla or mandible region. Also ideal for
XiVE®, FRIALIT® or FRIALIT®-2 cases involving very thin soft tissue.
The ANKYLOS® CERCON® Abutment is indicated for the support of highly esthetic single
tooth crowns in the anterior region of the maxilla and mandible, including where the mucosa
is very thin, in combination with implants of the ANKYLOS® implant system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072730 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072730: Friadent Cercon and Ankylos Cercon Balance Abutments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072730
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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