510(k) · Cleared

Cleared

Quantum Versatility Implant System

K991250510(k) TraditionalCleared Sep 20, 2001891-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

Quantum Bioengineering, Ltd. · DZE Implant, Endosseous, Root-Form

Cleared on Sep 20, 2001 as substantially equivalent to K820013 (Bofors Nobelpharma, Inc., 1982) and 11 other predicates after an 891-day review. Its family tree reaches back 1 generation to 1982. 2 later devices descend from it.

Decided: Sep 20, 2001
Review: 891 days
Class: Class II
Product code: DZE
Recalls: None
Predicates: 12

Its longest line of descent runs back 1 generation to K820013 (1982). 12 ancestors in all. 2 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK820013 Titanium Implant DevicesBofors Nobelpharma, Inc. · 1982
This deviceK991250 Quantum Versatility Implant SystemQuantum Bioengineering, Ltd. · 2001
Descendant · cites it directly · 1 of its ownK112279 Quantum Dental Implant SystemQuantum Bioengineering, Ltd. · 2012
Descendant · cites it directly · 0 of its ownK130787 Quantum Dental Implant SystemQuantum Bioengineering, Ltd. · 2013

Most influential descendants

Showing 2 of 2 · See all

K112279Quantum Dental Implant SystemQuantum Bioengineering, Ltd. · 2012 · cites it directly1descendant
K130787Quantum Dental Implant SystemQuantum Bioengineering, Ltd. · 2013 · 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)	K991250	Quantum Versatility Implant System	Quantum Bioengineering, Ltd.	2001	—
+1	K112279	Quantum Dental Implant System	Quantum Bioengineering, Ltd.	2012	—
+1	K130787	Quantum Dental Implant System	Quantum Bioengineering, Ltd.	2013	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1983	1	0
1985	2	0
1986	1	0
1989	3	0
1990	1	0
1994	2	0
1998	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0
2013	1	0

FIG. 1 — Lineage of K991250, 1982–2013Source: 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? (12)

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
*	K820013	Titanium Implant Devices Summary page 1 …tantially equivalent to the above preamendment devices. Some examples of other equivalent products are: Bofors Nobelpharma, Goteborg, Sweden: Titanium Implant Device, K-820013; Boehringer/Miter Corp. of Warsaw, IN: Titanoloy P.S.1.; Driskell Bioengineering, Inc., 22 Westerville, OH: DB P…	Bofors Nobelpharma, Inc.	1982	—
*	K830414	Titanaloy Submersible Implant System Summary page 1 …Quantum Implant system is most similar the DB Precision Implant system cleared in K-853788 which is very similar to the Titanaloy submersible implant system cleared in K-830414. Like many commercial implants, the Quantum devices are manufactured of high-purity (99+%) titanium, or titanium alloy (ASTM F 13…	Boehringer/Miter, Inc.	1983	—
*	K853788	DB Precision Implant System Summary page 2 …lant Device, K-820013; Boehringer/Miter Corp. of Warsaw, IN: Titanoloy P.S.1.; Driskell Bioengineering, Inc., 22 Westerville, OH: DB Precision Implants, K853788; Core-Vent Corp., Encino, CA: Screw- Vent Endosseous Implants, K-861426, A, B; Impla-med, Inc., Sunrise, FL: P.M.T. Surgical Impl…	Driskell Bioengineering	1985	—
*	K861426	Screw-Vent (TM) Implant/Endosseous Screw Implant Summary page 2 …S.1.; Driskell Bioengineering, Inc., 22 Westerville, OH: DB Precision Implants, K853788; 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; Steri-Oss (Subs. Denar, Anaheim, CA.), Denar…	Core-Vent Corp.	1986	—
*	K892124	Impla-Med Implant System Summary page 2 …sion Implants, K853788; 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; Steri-Oss (Subs. Denar, Anaheim, CA.), Denar Dental Implant, K-852802; Steri-Oss Implant, K-884845. Artech, Inc., Chantilly, VA…	Impla-Med	1989	—
*	K852802	Denar Dental Implant Summary page 2 …ous Implants, K-861426, A, B; Impla-med, Inc., Sunrise, FL: P.M.T. Surgical Implant Components, K-892124A; 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; Genentech, Seattle…	Denar Corp.	1985	—
*	K884845	Steri-Oss Summary page 2 …Impla-med, Inc., Sunrise, FL: P.M.T. Surgical Implant Components, K-892124A; 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; Genentech, Seattle WA: Sabertech, K- 924112; As…	Denar Corp.	1989	—
*	K891346	Artech Type SS Submerged Screw Implant Summary page 2 …2124A; 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; Genentech, Seattle WA: Sabertech, K- 924112; Astra Tech Inc., Astra Tech Implants, K-931767; and Vancouver Implant Res…	Artech Corp.	1989	—
*	K895267	Artech Type SS-HA Submerged Screw Implant Summary page 2 …ri-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; Genentech, Seattle WA: Sabertech, K- 924112; Astra Tech Inc., Astra Tech Implants, K-931767; and Vancouver Implant Resources, In…	Artech Corp.	1990	—
*	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. VIl. Labels and Instructions for Use are provided, as are labels for competitive products. VIIl. Intended Use: These devices a…	Saber Technology, Inc.	1994	—
*	K931767	Astra Tech Implants-Dental System Summary page 2 …45. Artech, Inc., Chantilly, VA: Artech Submerged Screw Implant, K-891346, K-895267; Genentech, Seattle WA: Sabertech, K- 924112; Astra Tech Inc., Astra Tech Implants, K-931767; and Vancouver Implant Resources, Inc., Simpler One Threaded Implant, K-974401. VIII. Clinical Discussion and Brief Literature R…	Astra Tech, Inc.	1994	—
*	K974401	4.0MM Simpler One Threaded Dental Implant Summary page 2 …5267; Genentech, Seattle WA: Sabertech, K- 924112; Astra Tech Inc., Astra Tech Implants, K-931767; and Vancouver Implant Resources, Inc., Simpler One Threaded Implant, K-974401. VIII. Clinical Discussion and Brief Literature Review. Endosseous implants, and especially those of titanium or titanium alloy,…	Vancouver Implant Resources, Inc.	1998	—

Also cleared against K820013: 3 other devices →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K112279	Quantum Dental Implant System	Quantum Bioengineering, Ltd.	2012	1
K130787	Quantum Dental Implant System	Quantum Bioengineering, Ltd.	2013	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 12 ancestors has a recall.
Of its descendants, K112279 (Quantum Bioengineering, Ltd., 2012) has gone furthest, with 1 descendant of its own.
3 other devices also cite its predicate K820013.

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/K991250 · printed Nov 4, 2026

Cite this page

510(k) Report. “K991250: Quantum Versatility Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991250

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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