510(k) · Cleared

Cleared

Crystal and Crystal-Seal Implants System

K980442510(k) TraditionalCleared Mar 16, 199840-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

Crystal Medical Technology · DZE Implant, Endosseous, Root-Form

Cleared on Mar 16, 1998 as substantially equivalent to K954432 (Crystal Medical Technology, 1996) and 10 other predicates after a 40-day review. Its family tree reaches back 1 generation to 1982. 1 later device descends from it.

Decided: Mar 16, 1998
Review: 40 days
Class: Class II
Product code: DZE
Recalls: None
Predicates: 11

Its longest line of descent runs back 1 generation to K820013 (1982). 11 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK820013 Titanium Implant DevicesBofors Nobelpharma, Inc. · 1982
This deviceK980442 Crystal and Crystal-Seal Implants SystemCrystal Medical Technology · 1998
Descendant · cites it directly · 0 of its ownK034067 Zti Implants System, DRM ImplantsDrm Research Laboratories, Inc. · 2004

Most influential descendants

Showing 1 of 1 · See all

K034067Zti Implants System, DRM ImplantsDrm Research Laboratories, Inc. · 2004 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K820013	Titanium Implant Devices	Bofors Nobelpharma, Inc.	1982	—
0 (this device)	K980442	Crystal and Crystal-Seal Implants System	Crystal Medical Technology	1998	—
+1	K034067	Zti Implants System, DRM Implants	Drm Research Laboratories, Inc.	2004	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1985	1	0
1986	1	0
1989	3	0
1990	1	0
1992	2	0
1994	1	0
1996	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0

FIG. 1 — Lineage of K980442, 1982–2004Source: 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? (11)

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
*	K954432	Crystal & Crystal-Plus Implants System Summary page 1 …ystal and Crystal Plus Implants System which received concurrence of substantial equivalence from the Food and Drug Administration in premarket notification submission K-954432. Like many commercial implants, the CRYSTAL devices are manufactured of high-purity (99+ %) titanium, or titanium alloy (ASTM F 1…	Crystal Medical Technology	1996	—
*	K924112	Hydroxylapatite Coated Saber Tech Series I & Series II Summary page 1 …pray. These devices are equivalent to various coated endosseous implants on the market, for example the Sabertech implants of Genentech, Inc., which were cleared under K-924112. VII. Labels and Instructions for Use are provided, as are labels for competitive products. VIII. Intended Use: These devices are…	Saber Technology, Inc.	1994	—
*	K820013	Titanium Implant Devices Summary page 2 …tal Plus System cleared by K-954432. Some examples of other equivalent products are: 19 Bofors Nobelpharma, Goteborg, Sweden: Titanium Implant Device, K-820013, Core-Vent Corp., Encino, CA: Screw-Vent Endosseous Implants, K-861426, A, B. Impla-med, Inc., Sunrise, FL: P.M.T. Surgical Impl…	Bofors Nobelpharma, Inc.	1982	—
*	K861426	Screw-Vent (TM) Implant/Endosseous Screw Implant Summary page 2 …roducts are: 19 Bofors Nobelpharma, Goteborg, Sweden: Titanium Implant Device, K-820013, Core-Vent Corp., Encino, CA: Screw-Vent Endosseous Implants, K-861426, A, B. Impla-med, Inc., Sunrise, FL: P.M.T. Surgical Implant Components, K-892124A, (Titanium Grade 3, ASTM F67-83); K-921854. S…	Core-Vent Corp.	1986	—
*	K892124	Impla-Med Implant System Summary page 2 …plant Device, K-820013, Core-Vent Corp., Encino, CA: Screw-Vent Endosseous Implants, K-861426, A, B. Impla-med, Inc., Sunrise, FL: P.M.T. Surgical Implant Components, K-892124A, (Titanium Grade 3, ASTM F67-83); K-921854. Steri-Oss (Subs. Denar, Anaheim, CA.), Denar Dental Implant, K-852802; Steri-Oss Im…	Impla-Med	1989	—
*	K921854	Impla-Med Hex Screw Implants, 18 and 20 MM Summary page 2 …cino, CA: Screw-Vent Endosseous Implants, K-861426, A, B. Impla-med, Inc., Sunrise, FL: P.M.T. Surgical Implant Components, K-892124A, (Titanium Grade 3, ASTM F67-83); K-921854. Steri-Oss (Subs. Denar, Anaheim, CA.), Denar Dental Implant, K-852802; Steri-Oss Implant, K-884845. Artech, Inc., Chantilly, V…	Impla-Med	1992	—
*	K852802	Denar Dental Implant Summary page 2 …., Sunrise, FL: P.M.T. Surgical Implant Components, K-892124A, (Titanium Grade 3, ASTM F67-83); K-921854. Steri-Oss (Subs. Denar, Anaheim, CA.), Denar Dental Implant, K-852802; Steri-Oss Implant, K-884845. Artech, Inc., Chantilly, VA: Artech Submerged Screw Implant, K-891346, K-895267. Odontit, SA, Buen…	Denar Corp.	1985	—
*	K884845	Steri-Oss Summary page 2 …al Implant Components, K-892124A, (Titanium Grade 3, ASTM F67-83); K-921854. Steri-Oss (Subs. Denar, Anaheim, CA.), Denar Dental Implant, K-852802; Steri-Oss Implant, K-884845. Artech, Inc., Chantilly, VA: Artech Submerged Screw Implant, K-891346, K-895267. Odontit, SA, Buenos Aires, Argentina, Osseo. I…	Denar Corp.	1989	—
*	K891346	Artech Type SS Submerged Screw Implant Summary page 2 …854. Steri-Oss (Subs. Denar, Anaheim, CA.), Denar Dental Implant, K-852802; Steri-Oss Implant, K-884845. Artech, Inc., Chantilly, VA: Artech Submerged Screw Implant, K-891346, K-895267. Odontit, SA, Buenos Aires, Argentina, Osseo. Implants System, K-915375. Genentech, Seattle WA: K-924112 VIII. Clinic…	Artech Corp.	1989	—
*	K895267	Artech Type SS-HA Submerged Screw Implant Summary page 2 …i-Oss (Subs. Denar, Anaheim, CA.), Denar Dental Implant, K-852802; Steri-Oss Implant, K-884845. Artech, Inc., Chantilly, VA: Artech Submerged Screw Implant, K-891346, K-895267. Odontit, SA, Buenos Aires, Argentina, Osseo. Implants System, K-915375. Genentech, Seattle WA: K-924112 VIII. Clinical Discuss…	Artech Corp.	1990	—
*	K915375	Odontit Osseointegrated Implants System Summary page 2 …-Oss Implant, K-884845. Artech, Inc., Chantilly, VA: Artech Submerged Screw Implant, K-891346, K-895267. Odontit, SA, Buenos Aires, Argentina, Osseo. Implants System, K-915375. Genentech, Seattle WA: K-924112 VIII. Clinical Discussion and Brief Literature Review: Endosseous implants, and especially tho…	Odontit Systeme	1992	—

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K034067	Zti Implants System, DRM Implants	Drm Research Laboratories, Inc.	2004	0

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?

None of the 11 ancestors has a recall.
Of its descendants, K034067 (Drm Research Laboratories, Inc., 2004) has gone furthest, with 0 descendants of its own.

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.

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?

This device is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K980442 · printed Nov 4, 2026

Cite this page

510(k) Report. “K980442: Crystal and Crystal-Seal Implants System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980442

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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