510(k) · Cleared

Cleared

ZL Microdent Natural Lock Implant System

K133706510(k) TraditionalCleared Aug 21, 2014261-day reviewClass II21 CFR 872.3640

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

Zl Microdent-Attachment GmbH & Co. KG · DZE Implant, Endosseous, Root-Form

Cleared on Aug 21, 2014 as substantially equivalent to K031345 (Nobel Biocare Uas, Inc., 2003) and 2 other predicates after a 261-day review. Its family tree reaches back 2 generations to 2003.

Decided: Aug 21, 2014
Review: 261 days
Class: Class II
Product code: DZE
Recalls: None
Predicates: 3

Its longest line of descent runs back 2 generations to K023952 (2003). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK023952 Replace One Piece Implant, HA, Replace One Piece Implant, TiuniteNobel Biocare Uas, Inc. · 2003
1 generation backK031345 Nobel Direct, Models 30937, 30938Nobel Biocare Uas, Inc. · 2003
This deviceK133706 ZL Microdent Natural Lock Implant SystemZl Microdent-Attachment GmbH & Co. KG · 2014

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K023952	Replace One Piece Implant, HA, Replace One Piece Implant, Tiunite	Nobel Biocare Uas, Inc.	2003	—
−1	K031345	Nobel Direct, Models 30937, 30938	Nobel Biocare Uas, Inc.	2003	—
0 (this device)	K133706	ZL Microdent Natural Lock Implant System	Zl Microdent-Attachment GmbH & Co. KG	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2006	2	0

FIG. 1 — Lineage of K133706, 2003–2014Source: 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 DZE? 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 DZE device

#1 K211090 ZENEX Implant Systemscore 25.4 · 15 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? (3)

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
*	K031345	Nobel Direct, Models 30937, 30938 Summary page 6 …2 Classification name: Endosseous dental implant, Dental (21 CFR 872.3640- DZE) Predicate devices: K031345 Nobel Direct Nobel Biocare USA Inc., 22715 Savi Ranch Parkway, Yorba Linda, CA 92887, USA K062281 Zimmer One Piece,…	Nobel Biocare Uas, Inc.	2003	—
*	K062281	Zimmer One-Piece Implant, 4.7MM, Straight, Models ZOP47S10, ZOP47S11, ZOP47S13, ZOP47S16 Summary page 6 …tal implant, Dental (21 CFR 872.3640- DZE) Predicate devices: K031345 Nobel Direct Nobel Biocare USA Inc., 22715 Savi Ranch Parkway, Yorba Linda, CA 92887, USA K062281 Zimmer One Piece, 4,7mm K052997 Zimmer Once Piece Zimmer Dental Inc., 1900 Aston Ave., Carlsbad, CA 92008, USA…	Zimmer Dental, Inc.	2006	—
*	K052997	Zimmer Dental One-Piece Implant Summary page 6 …DZE) Predicate devices: K031345 Nobel Direct Nobel Biocare USA Inc., 22715 Savi Ranch Parkway, Yorba Linda, CA 92887, USA K062281 Zimmer One Piece, 4,7mm K052997 Zimmer Once Piece Zimmer Dental Inc., 1900 Aston Ave., Carlsbad, CA 92008, USA…	Zimmer Dental, Inc.	2006	1

Also cleared against K031345: 4 other devices →

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 11 years and passes through 2 companies; a new generation was cleared every 11.1 years on median.
1 of the 4 ancestors has a recall of any class.
4 other devices also cite its predicate K031345.

How does its category compare?

All DZE devices

DZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · DZE

31in 2025

2007high 61 (2008) · low 26 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DZE

184in 2025

2007high 265 (2014) · low 107 (2007)2026

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

Recalls per year · DZE

1in 2025

2007high 15 (2016) · low 0 (2011)2026

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

Adverse event reports per year · DZE

465,788in 2025

2007high 537,585 (2023) · low 164 (2009)2025

MAUDE reports naming product code DZE, 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	43	107	11	225
2008	61	118	4	393
2009	41	110	3	164
2010	34	162	3	360
2011	26	194	0	362
2012	39	174	11	358
2013	42	195	1	391
2014	36	265	7	1,124
2015	36	215	3	2,894
2016	40	219	15	1,116
2017	48	223	4	9,719
2018	41	200	4	12,892
2019	31	231	8	167,016
2020	41	230	0	255,524
2021	34	182	6	479,618
2022	34	243	0	483,224
2023	35	248	0	537,585
2024	40	222	1	473,629
2025	31	184	1	465,788
2026	15	194	2	—

What is it indicated for?

The NaturaLLock implant system is an endosseous dental implant system made of titanium. NaturaLLock implants are indicated for the support and retention of fixed single tooth and fixed partial denture restorations in the molar, premolar, cuspid, and incisor regions of partially edentulous jaws. NaturaLLock implants may be loaded immediately in the anterior mandibular arch if four are splinted together with a bar. NaturaLLock implants may be immediately restored with a temporary prosthesis that is not in functional occlusion.

The implants are offered in sterile condition, all other components can be sterilized in an autoclave .

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K133706 · printed Nov 6, 2026

Cite this page

510(k) Report. “K133706: ZL Microdent Natural Lock Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133706

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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