510(k) Report

510(k) · Cleared

Cleared

Altatec Ceramic Abutment

K032448510(k) SpecialCleared Aug 22, 200314-day reviewClass II21 CFR 872.3630

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

Altatec Biotechnologies · NHA Abutment, Implant, Dental, Endosseous

Cleared on Aug 22, 2003 after a 14-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 252 later devices descend from it.

Decided
Aug 22, 2003
Review
14 days
Class
Class II
Product code
NHA
Recalls
None
Predicates
0

252 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2008: 1 descendant cleared2010: 1 descendant cleared2012: 3 descendants cleared2013: 3 descendants cleared2011: 2 descendants cleared2016: 14 descendants cleared2021: 22 descendants cleared2014: 7 descendants cleared2018: 14 descendants cleared2020: 22 descendants cleared2015: 11 descendants cleared2017: 12 descendants cleared2023: 32 descendants cleared2019: 13 descendants cleared2024: 35 descendants cleared2022: 19 descendants cleared2025: 27 descendants cleared2026: 14 descendants cleared200020052010201520202025
  1. This deviceK032448 Altatec Ceramic AbutmentAltatec Biotechnologies · 2003
  2. Descendant · cites it directly · 240 of its ownK100152 Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010
  3. Descendant · cites it directly · 176 of its ownK072055 Lava Frame, Lava Frame Shade3M Espe AG Dental Products · 2008
  4. Descendant · 2 generations on · 165 of its ownK120822 Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase…Institut Straumann AG · 2012
  5. Descendant · 3 generations on · 129 of its ownK150203 Medentika CAD/CAM AbutmentsMedentika GmbH · 2015
  6. Descendant · 3 generations on · 89 of its ownK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015

Showing 5 of 252 descendants. See all descendants

Descendants cleared per year

2008: 12010: 12011: 22012: 32013: 32014: 72015: 112016: 142017: 122018: 142019: 132020: 222021: 222022: 192023: 322024: 352025: 272026: 14
2008high 35 (2024) · low 0 (2009)2026

Most influential descendants

Showing 5 of 252 · See all
  • K100152Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010 · cites it directly240descendants
  • K072055Lava Frame, Lava Frame Shade3M Espe AG Dental Products · 2008 · cites it directly176descendants
  • K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG · 2012 · 2 generations on165descendants
  • K150203Medentika CAD/CAM AbutmentsMedentika GmbH · 2015 · 3 generations on129descendants
  • K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015 · 3 generations on89descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K032448Altatec Ceramic AbutmentAltatec Biotechnologies2003—
+1K100152Sirona Cad/Cam SystemSirona Dental Systems GmbH2010—
+1K072055Lava Frame, Lava Frame Shade3M Espe AG Dental Products2008—
+2K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN…Institut Straumann AG2012—
+3K150203Medentika CAD/CAM AbutmentsMedentika GmbH2015—
+3K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201010
201120
201230
201330
201470
2015110
2016140
2017120
2018140
2019130
2020220
2021220
2022190
2023320
2024350
2025270
2026140
FIG. 1 — Lineage of K032448, 2003–2026Source: 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 510(k) statement (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. #1 K222288 DESS Dental Smart Solutionsscore 30.6 · 19 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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (252)

See all 252

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K100152Sirona Cad/Cam SystemSirona Dental Systems GmbH2010240
K072055Lava Frame, Lava Frame Shade3M Espe AG Dental Products2008176

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, K100152 (Sirona Dental Systems GmbH, 2010) has gone furthest, with 240 descendants of its own.

How does its category compare?

All NHA devices

NHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NHA

40in 2025

2007: 382008: 312009: 302010: 192011: 312012: 252013: 222014: 272015: 292016: 382017: 312018: 312019: 282020: 382021: 292022: 332023: 512024: 432025: 402026 (partial year): 23
2007high 51 (2023) · low 19 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NHA

147in 2025

2007: 91 days median2008: 90 days median2009: 95 days median2010: 162 days median2011: 130 days median2012: 171 days median2013: 184 days median2014: 160 days median2015: 151 days median2016: 202 days median2017: 188 days median2018: 200 days median2019: 160 days median2020: 153 days median2021: 211 days median2022: 142 days median2023: 147 days median2024: 158 days median2025: 147 days median2026 (partial year): 169 days median
2007high 211 (2021) · low 90 (2008)2026

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

Recalls per year · NHA

1in 2025

2007: 12008: 22011: 52012: 12013: 12015: 12016: 362017: 22018: 12020: 72023: 32025: 12026 (partial year): 3
2007high 36 (2016) · low 0 (2009)2026

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

Adverse event reports per year · NHA

838in 2025

2007: 12008: 82009: 302010: 612011: 562012: 52013: 1432014: 1462015: 8582016: 3142017: 5772018: 5912019: 5302020: 4582021: 5462022: 4972023: 6182024: 6352025: 838
2007high 858 (2015) · low 1 (2007)2025

MAUDE reports naming product code NHA, 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
2007389111
2008319028
20093095030
201019162061
201131130556
20122517115
2013221841143
2014271600146
2015291511858
20163820236314
2017311882577
2018312001591
2019281600530
2020381537458
2021292110546
2022331420497
2023511473618
2024431580635
2025401471838
2026231693—

What is it indicated for?

ALTATEC BIOTECHNOLOGIES implants are indicated for single tooth replacement, as immediate abutments on long span to bridgework, as distal abutments on free-end edentulous areas to be restored with fixed bridgework, to support overdentures in totally or partially edentulous arches, and as abutments supporting a full arch fixed prosthesis in the totally edentulous mandible or maxila.

The Ti-Ceramic abutment is used with the mentioned implant supported restorations where high aesthetics are desired.

Indications for use as stated in the FDA 510(k) statement.

More from Altatec Biotechnologies

4 FDA decisions under this applicant name. See the company

  • K000065Camlog Cylinder Implant SystemAltatec Biotechnologies · 2000
  • K000099Camlog Screw Implant SystemAltatec Biotechnologies · 2000
  • K000100Camlog Rootform Implant SystemAltatec Biotechnologies · 2000

Recent decisions in NHA

The NHA category page

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  • K262207Cemented Plus AbutmentUnidental Co., Ltd. · 2026
  • K260940BellaTek BarsZimVie US Corp, LLC · 2026
  • K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment…Nobel Biocare AB · 2026
  • K261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A. · 2026

https://510kreport.com/device/K032448 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032448: Altatec Ceramic Abutment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032448

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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