510(k) Report

510(k) · Cleared

Cleared

Miniscrews Anchoring System, M.a.S.

K062367510(k) TraditionalCleared Dec 8, 2006116-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

Micerium S.P.A. · DZE Implant, Endosseous, Root-Form

Cleared on Dec 8, 2006 as substantially equivalent to K050568 (Ortholution Co., Ltd., 2005) and 3 other predicates after a 116-day review. Its family tree reaches back 6 generations to 1990. 1 later device descends from it.

Decided
Dec 8, 2006
Review
116 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
5

Its longest line of descent runs back 6 generations to K894844 (1990). 18 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 1 other ancestor2000: 1 other ancestor1998: 1 other ancestor1997: 2 other ancestors1995: 2 other ancestors1994: 2 other ancestors1993: 3 other ancestors2008: 1 descendant clearedK894844 · Bonefit Implant System Accessories & Instruments · Straumann Institute, Ltd. · 1990K973353 · Bonding Base · Straumann USA · 1997K982509 · Ortho Implant and Accessories · Straumann USA · 1998×2: 2 generations cleared close together, K031936 (2004), K033767 (2004) K042965 · Tomas Pin · Dentaurum, Inc. · 20051990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors3 generations back: 3 other ancestors4 generations back: 7 other ancestors 1 generation forward: 1 descendant K042965 · Tomas Pin · Dentaurum, Inc. · 2005K033767 · Dual Top Anchor System Screws · Jeil Medical Corporation · 2004K031936 · Osteomed Orthodontic Screw System · Osteomed LP · 2004K982509 · Ortho Implant and Accessories · Straumann USA · 1998K973353 · Bonding Base · Straumann USA · 1997K894844 · Bonefit Implant System Accessories & Instruments · Straumann Institute, Ltd. · 1990−50
  1. Root · 6 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
  2. 5 generations backK973353 Bonding BaseStraumann USA · 1997
  3. 4 generations backK982509 Ortho Implant and AccessoriesStraumann USA · 1998
  4. 3 generations backK031936 Osteomed Orthodontic Screw SystemOsteomed LP · 2004
  5. 2 generations backK033767 Dual Top Anchor System ScrewsJeil Medical Corporation · 2004
  6. 1 generation backK042965 Tomas PinDentaurum, Inc. · 2005
  7. This deviceK062367 Miniscrews Anchoring System, M.a.S.Micerium S.P.A. · 2006
  8. Descendant · cites it directly · 0 of its ownK072917 JJG Evolution Orthodontic Implant SystemOdontit S.A. · 2008

Most influential descendants

Showing 1 of 1 · See all
  • K072917JJG Evolution Orthodontic Implant SystemOdontit S.A. · 2008 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K894844Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd.1990—
−5K973353Bonding BaseStraumann USA1997—
−4K982509Ortho Implant and AccessoriesStraumann USA1998—
−3K031936Osteomed Orthodontic Screw SystemOsteomed LP2004—
−2K033767Dual Top Anchor System ScrewsJeil Medical Corporation2004—
−1K042965Tomas PinDentaurum, Inc.2005—
0 (this device)K062367Miniscrews Anchoring System, M.a.S.Micerium S.P.A.2006—
+1K072917JJG Evolution Orthodontic Implant SystemOdontit S.A.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199330
199420
199520
199720
199810
200010
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
FIG. 1 — Lineage of K062367, 1990–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K211090 ZENEX Implant Systemscore 25.4 · 15 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (5)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K050568Orlus Mini Screw
Summary page 1
…small implant systems currently on the market. A list of these is provided, and includes: Orlus Mini Screw, cleared by the Ortholution Co., LTD, in K050568; Tomas Pin, cleared by Dentaurum, Inc., in K042965; Dual Top Anchor System Screws, cleared by Jeil Me…
Ortholution Co., Ltd.2005—
*K042965Tomas Pin
Summary page 1
…these is provided, and includes: Orlus Mini Screw, cleared by the Ortholution Co., LTD, in K050568; Tomas Pin, cleared by Dentaurum, Inc., in K042965; Dual Top Anchor System Screws, cleared by Jeil Medical Corp., in K033767; Ostemed Orthodontic Screw…
Dentaurum, Inc.2005—
*K033767Dual Top Anchor System Screws
Summary page 1
…ion Co., LTD, in K050568; Tomas Pin, cleared by Dentaurum, Inc., in K042965; Dual Top Anchor System Screws, cleared by Jeil Medical Corp., in K033767; Ostemed Orthodontic Screw System, cleared by OsteoMed, LP in K0312936; Implant Orthodontic Anchor System,…
Jeil Medical Corporation2004—
Kept off the family treeK031293FDA’s K031293 is Synthetic (White) Vinyl Patient Examination Gloves-Powder Free
Our reading of the summary gave K031293, FDA’s number for Synthetic (White) Vinyl Patient Examination Gloves-Powder… (Shijiazhuang Eversharp Plastic Products Co., Ltd.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Ostemed Orthodontic Screw System”. Kept off the family tree.
Summary page 1
…42965; Dual Top Anchor System Screws, cleared by Jeil Medical Corp., in K033767; Ostemed Orthodontic Screw System, cleared by OsteoMed, LP in K0312936; Implant Orthodontic Anchor System, cleared by Nobel Biocare USA, Inc. in K000643. The implant is…
Shijiazhuang Eversharp Plastic Products Co., Ltd.2003—
*K000643Inplant Orthodontic Anchor System
Summary page 1
…temed Orthodontic Screw System, cleared by OsteoMed, LP in K0312936; Implant Orthodontic Anchor System, cleared by Nobel Biocare USA, Inc. in K000643. The implant is intended to provide a fixed anchorage point for attachment of orthodontic appliance…
Nobel Biocare Uas, Inc.2000—

Also cleared against K050568: 3 other devices →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K072917JJG Evolution Orthodontic Implant SystemOdontit S.A.20080

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 16 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
  • None of the 18 ancestors has a recall.
  • Of its descendants, K072917 (Odontit S.A., 2008) has gone furthest, with 0 descendants of its own.
  • 3 other devices also cite its predicate K050568.

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

2007: 432008: 612009: 412010: 342011: 262012: 392013: 422014: 362015: 362016: 402017: 482018: 412019: 312020: 412021: 342022: 342023: 352024: 402025: 312026 (partial year): 15
2007high 61 (2008) · low 26 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DZE

184in 2025

2007: 107 days median2008: 118 days median2009: 110 days median2010: 162 days median2011: 194 days median2012: 174 days median2013: 195 days median2014: 265 days median2015: 215 days median2016: 219 days median2017: 223 days median2018: 200 days median2019: 231 days median2020: 230 days median2021: 182 days median2022: 243 days median2023: 248 days median2024: 222 days median2025: 184 days median2026 (partial year): 194 days median
2007high 265 (2014) · low 107 (2007)2026

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

Recalls per year · DZE

1in 2025

2007: 112008: 42009: 32010: 32012: 112013: 12014: 72015: 32016: 152017: 42018: 42019: 82021: 62024: 12025: 12026 (partial year): 2
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

2007: 2252008: 3932009: 1642010: 3602011: 3622012: 3582013: 3912014: 1,1242015: 2,8942016: 1,1162017: 9,7192018: 12,8922019: 167,0162020: 255,5242021: 479,6182022: 483,2242023: 537,5852024: 473,6292025: 465,788
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20074310711225
2008611184393
2009411103164
2010341623360
2011261940362
20123917411358
2013421951391
20143626571,124
20153621532,894
201640219151,116
20174822349,719
201841200412,892
2019312318167,016
2020412300255,524
2021341826479,618
2022342430483,224
2023352480537,585
2024402221473,629
2025311841465,788
2026151942—

What is it indicated for?

This device is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only on adults over the age of 12.

Indications for use as stated in the FDA summary.

Also cleared against K050568

3 other devices cite the same predicate.

  • K082838Orlus Mini ScrewOrtholution Co., Ltd. · 2008
  • K072917JJG Evolution Orthodontic Implant SystemOdontit S.A. · 2008
  • K052968Modification to: Orlus Mini ScrewOrtholution Co., Ltd. · 2006

More from Micerium S.P.A.

6 FDA decisions under this applicant name. See the company

  • K103474Ena Temp and Enamel Plus Temp (Two Different Proprietary Names for the Same Product)Micerium S.P.A. · 2011
  • K072978Tender Ortho Bond-Ena Bond-Ena EtchMicerium S.P.A. · 2008
  • K063170Tender FiberMicerium S.P.A. · 2007
  • K062355Ena CemMicerium S.P.A. · 2006
  • K062906Ena Hfo Composite SystemMicerium S.P.A. · 2006

Recent decisions in DZE

The DZE category page

  • K261295MultiNeO Dental Implant SystemAlpha Bio Tec, Ltd. · 2026
  • K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC · 2026
  • K260463ZEROS Dental Implant SystemZeros Co., Ltd. · 2026
  • K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd. · 2026
  • K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd. · 2026

https://510kreport.com/device/K062367 · printed Nov 6, 2026

Cite this page

510(k) Report. “K062367: Miniscrews Anchoring System, M.a.S..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062367

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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