510(k) · Cleared

Cleared

Guided Surgery Kit

K231087510(k) TraditionalCleared Aug 16, 2023121-day reviewClass II21 CFR 872.4120

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

Implant Direct Sybron Manufacturing, LLC · DZI Drill, Bone, Powered

Cleared on Aug 16, 2023 as substantially equivalent to K200265 (Implant Direct Sybron Manufacturing, LLC, 2020) after a 121-day review. Its family tree reaches back 3 generations to 1990.

Decided: Aug 16, 2023
Review: 121 days
Class: Class II
Product code: DZI
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K894844 (1990). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
2 generations backK082532 Straumann Guided InstrumentsStraumann USA · 2008
1 generation backK200265 Surgical DrillsImplant Direct Sybron Manufacturing, LLC · 2020
This deviceK231087 Guided Surgery KitImplant Direct Sybron Manufacturing, LLC · 2023

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K894844	Bonefit Implant System Accessories & Instruments	Straumann Institute, Ltd.	1990	—
−2	K082532	Straumann Guided Instruments	Straumann USA	2008	—
−1	K200265	Surgical Drills	Implant Direct Sybron Manufacturing, LLC	2020	—
0 (this device)	K231087	Guided Surgery Kit	Implant Direct Sybron Manufacturing, LLC	2023	—

FIG. 1 — Lineage of K231087, 1990–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 DZI? 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 DZI device

#1 K253776 Implantmed Plus II & Piezomed Plus II Modulescore 12.1 · 3 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

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	Applicant	Decided	Recalls
*	K200265	Surgical Drills Summary page 4 …4120 Device Class: II Primary Product Code: DZI Secondary Product Code: KCT iii. Predicate Devices Predicate Device 510(k) #: K200265 Propriety Name: Surgical Drills Manufacturer: Implant Direct Sybron Manufacturing, LLC Common Name:…	Implant Direct Sybron Manufacturing, LLC	2020	—
†	K202524	Standard Sterilizable Tray	Implant Direct Sybron Manufacturing, LLC	2021	—

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 33 years and passes through 3 companies; a new generation was cleared every 11.7 years on median.
None of the 3 ancestors has a recall.

How does its category compare?

All DZI devices

DZI Drill, Bone, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.

FDA decisions per year · DZI

1in 2025

2007high 5 (2009) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DZI

300in 2020

2007high 300 (2020) · low 123 (2015)2026

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

Recalls per year · DZI

1in 2009

2007high 1 (2009) · low 0 (2007)2026

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

Adverse event reports per year · DZI

39in 2025

2007high 84 (2021) · low 15 (2010)2025

MAUDE reports naming product code DZI, 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	2	—	0	53
2008	4	171	0	45
2009	5	220	1	22
2010	0	—	0	15
2011	2	—	0	42
2012	4	191	0	25
2013	0	—	0	57
2014	1	—	0	50
2015	3	123	0	39
2016	1	—	0	43
2017	0	—	0	38
2018	3	290	0	73
2019	0	—	0	50
2020	3	300	0	55
2021	0	—	0	84
2022	0	—	0	63
2023	1	—	0	63
2024	2	—	0	58
2025	1	—	0	39
2026	2	—	0	—

What is it indicated for?

The Guided Surgery Kit is designed to hold various dental surgical drills and instruments to organize, steam sterilize, and transport between uses. The guided surgical drills are intended to cut into maxilla or mandible to create an osteotomy for endosseous dental implant placement. The kit is to be enclosed in a FDA cleared steam sterilizable wrap (maximum thickness KC300) and sterilized in a FDA cleared sterilizer for one of the following cycles: (1)…

Read the full statement (136 words)

The kit is to be enclosed in a FDA cleared steam sterilizable wrap (maximum thickness KC300) and sterilized in a FDA cleared sterilizer for one of the following cycles:

(1) Prevacuum Steam – At 132°C for 4 minutes with a 20 minute dry time.

(2) Gravity Steam – At 132°C for 15 minutes with a 30 minute dry time.

• The kit is intended for sterilization of non-porous loads.

• Do not stack kits during sterilization.

• Implant Direct Sybron Manufacturing LLC does not make any lumen claims for the Sterilizable Guided kit.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K231087 · printed Nov 5, 2026

Cite this page

510(k) Report. “K231087: Guided Surgery Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K231087

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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