# K112787: Kerator

- Pathway: 510(k) (Traditional)
- Applicant: Kj Meditech Co., Ltd.
- Decided: Aug 8, 2012 after 317 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K894595 (1990). 46 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994257: Locator Implant Anchor, Zest Anchors, Inc. (2000) Summary page 1.
- K944683: Branemark System 3.3MM Fixture, Nobelpharma USA, Inc. (1995) Summary page 1.
- K925764: Branemark System 4.00 MM Fixture, Nobelpharma USA, Inc. (1993) Summary page 1.
- K925761: Branemark System 5.0 X 14MM Fixture, Nobelpharma USA, Inc. (1993) Summary page 1.
- K091239: Astra Tech Implant System, Astra Tech AB (2009) Summary page 1.
- K023113: Replace Tiunite Endosseous Implant, Nobel Biocare Uas, Inc. (2002) Summary page 1.
- K050712: 4.5.* 6.0MM Dental Implant and 6.0*6.0 MM Dental Implant, Bicon, Inc. (2005) Summary page 1.
- K101849: Bicon Dental Implant System 3.0MM Bicon Dental Implant, Bicon, LLC (2010) Summary page 1.
- K953101: Paragon Implant System, Core-Vent Bio-Engineering, Inc. (1995)
- K033984: Straumann Dental Implant System, Institut Straumann AG (2004) Summary page 2.

## Most influential descendants
- K241183: ISO Abutment (2025), 0 descendants of its own
- K173141: CSM Submerged3-L Implant System (2018), 0 descendants of its own
- K132144: Kerator (2014), 0 descendants of its own

## Indications for use
The Kerator is appropriate for use with overdentures or partial dentures retained in whole or in part by endosseoius implants in the mandible or maxilla. The Kerator is compatible with the following fixtures. Kerator Model No. — Fixture Description — Manufacturer B331 - B337 — Branemark 3.3 Type — NOBELPHARMA USA, INC. B401 - B407 — Branemark 4.0 Type — NOBELPHARMA USA, INC. B501 - B507 — Branemark 5.0 Type — NOBELPHARMA USA, INC. AS351 - AS357 — Astra 3.5 Type — ASTRA TECH AB AS401 - AS407 — Astra 4.0 Type — ASTRA TECH AB G400 - G406 — Astra 4.0 Type — ASTRA TECH AB SRS350 - SRS356 — Replace 3.5 Type — Nobel Biocare USA, Inc. SRS450 - SRS457 — Replace 4.3 Type — Nobel Biocare USA, Inc. SRS500 - SRS506 — Replace 5.0 Type — Nobel Biocare USA, Inc. BC201 - BC207 — Bicon 2.0 Type — BICON, INC. BC301 - BC307 — Bicon 3.0 Type — BICON, INC. PA350 - PA356 — Paragon 3.5 Type — CORE-VENT ENGINEERING, INC. PA450 - PA456 — Paragon 4.5 Type — CORE-VENT ENGINEERING, INC. T40 — ITI 4.0 Type — INSTITUT STRAUMANN AG

Source page: https://510kreport.com/device/K112787
Methodology: https://510kreport.com/methodology