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Calibrated Drills

by 3DIEMME srl 27 variants

Ref 3DMUS00613.30.160, 3DMUS00613.30.130, 3DMUS00613.28.080Z, 3DMUS00613.23.085, 3DMUS00613.23.100, 3DMUS00613.28.130Z, 3DMUS00613.38.080Z, 3DMUS00613.24.100Z, 3DMUS00613.34.115, 3DMUS00613.24.115Z, 3DMUS00613.38.085, 3DMUS00613.34.085, 3DMUS00613.16.070, 3DMUS00613.28.150, 3DMUS00613.28.115Z, 3DMUS00613.34.160Z, 3DMUS00613.34.115Z, 3DMUS00613.34.130Z, 3DMUS00613.30.115, 3DMUS00613.23.160, 3DMUS00613.16.115, 3DMUS00613.21.150, 3DMUS00613.44.115Z, 3DMUS00613.44.160Z, 3DMUS00613.44.080Z, 3DMUS00613.38.160, 3DMUS00613.42.085, 3DMUS00613.38.130, 3DMUS00619ZModel STRMTAGL-1, STRMTAGL-2, STRMTAGL-3, STRMTAGL-4, STRMTAGL-5, STRMTAGL-6, STRMTAGL-7

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08050038833561 UDI-DI Date30 Jun 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number805003883STRMTAGLC3 Basic UDI-DI Date8 Apr 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Calibrated Drills EUDAMED
RealGUIDE Surgical Instruments GUDID
Generic Name
Fixture/appliance dental drill bit, reusable
Device Name
Surgical instruments for dental implantology - Cutting Tools
Model / Ref / Catalog
STRMTAGL-1, STRMTAGL-2, STRMTAGL-3, STRMTAGL-4, STRMTAGL-5, STRMTAGL-6, STRMTAGL-7, 3DMUS00613.30.160, 3DMUS00613.30.130, 3DMUS00613.28.080Z, 3DMUS00613.23.085, 3DMUS00613.23.100, 3DMUS00613.28.130Z, 3DMUS00613.38.080Z, 3DMUS00613.24.100Z, 3DMUS00613.34.115, 3DMUS00613.24.115Z, 3DMUS00613.38.085, 3DMUS00613.34.085, 3DMUS00613.16.070, 3DMUS00613.28.150, 3DMUS00613.28.115Z, 3DMUS00613.34.160Z, 3DMUS00613.34.115Z, 3DMUS00613.34.130Z, 3DMUS00613.30.115, 3DMUS00613.23.160, 3DMUS00613.16.115, 3DMUS00613.21.150, 3DMUS00613.44.115Z, 3DMUS00613.44.160Z, 3DMUS00613.44.080Z, 3DMUS00613.38.160, 3DMUS00613.42.085, 3DMUS00613.38.130, 3DMUS00619Z
Primary DI / UDI-DI
08050038833561, 08050038833554, 08050038833462, 08050038833325, 08050038833332, 08050038833493, 08050038833684, 08050038833417, 08050038833622, 08050038833424, 08050038833691, 08050038833592, 08050038833288, 08050038833509, 08050038833486, 08050038833677, 08050038833639, 08050038833646, 08050038833547, 08050038833394, 08050038833295, 08050038833318, 08050038833813, 08050038833837, 08050038833790, 08050038833738, 08050038833745, 08050038833721, 08050038833851
Basic UDI-DI
805003883STRMTAGLC3
FDA Product Code
NDP
EMDN Code
Q010399 Surgical dental devices - other
GMDN Term
Fixture/appliance dental drill bit, reusable
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
872.3980
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
IT-MF-000016005

Other devices from 3DIEMME SRL

See all devices from 3DIEMME SRL →

Properties

  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No