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Pilot Drill S-5.5, 2.5/1.8mmDx6.0mmL

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref GS0625Model Guided Pilot DrillRef MGSD0625Model Guided Surgery Pilot Drills

by Adin Dental Implant Systems LTD.

Identity

Trade Name
Pilot Drill S-5.5, 2.5/1.8mmDx6.0mmL EUDAMEDFDA UDI
Generic Name
Fluted surgical drill bit, reusable FDA UDI
Model / Reference
Guided Pilot Drill EUDAMED
GS0625 EUDAMEDFDA UDI
Guided Surgery Pilot Drills EUDAMED
MGSD0625 EUDAMED

Identifiers

Primary DI / UDI-DI
07290105152107 EUDAMEDFDA UDI
04260525163925 EUDAMED
Basic UDI-DI
729010515GuidPilotDrillRJ EUDAMED
426052516GuidPilotDrillQK EUDAMED
FDA Product Code
EJL FDA UDI
EMDN Code
Z12110102 DENTAL DRILLS EUDAMED
GMDN Term
Fluted surgical drill bit, reusable FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class I FDA UDI
Regulation Number
872.3240 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Pilot Drill S-5.5, 2.5/1.8mmDx6.0mmL by Adin Dental Implant Systems Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

EUDAMED SRN
IL-MF-000014625
Authorised Representative
MedNet EC-REP GmbH DE-AR-000000002

Sources (3)

  • EUDAMED 3ab143a6-107a-4540-9437-d8ff9d60b4e2 61 fields · synced Jul 10, 2026
  • EUDAMED 535ca2a5-50ca-4b7a-8b82-93ce36831149 61 fields · synced May 19, 2026
  • FDA UDI 95ff061a-9cd6-44b1-9d1d-dd12a40a2462 32 fields · synced May 30, 2026