FDA.reportPublic FDA data

Pilot Drill NC L1.6mmD

Primary DI
07290116773315
Brand
Pilot Drill NC L1.6mmD
Company
ADIN DENTAL IMPLANT SYSTEMS LTD
Model
NL16
Published
2025-11-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EJLBur, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
EJLBur, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07290116773315PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07290116773315072901167733157290116773315

GMDN Terms

TermDefinition
Fixture/appliance dental drill bit, reusableA shaft of metal intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. The device is typically available in a set of graduated sizes and various forms and functions (e.g., guide, pilot, twist, cortical, conical). It is attached to a manual or power tool handpiece that provides rotation. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
533289435
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

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07290116777658OnePiece Wrench RatchetRA10002025-12-18
07290116777665OnePiece Ratchet Hexagon AdapterRA10012025-12-18
07290116777672OnePiece Prosthetic Torque Ratchet 35 NcmRA10352025-12-18
07290116777689OnePiece Surgical Torque Ratchet 80 NcmRA10802025-12-18
07290116777696OnePiece Surgical Torque Ratchet 200 NcmRA12002025-12-18
07290116777702OnePiece UniV Wrench RatchetRA20002025-12-18
07290116777719OnePiece Standard Prosthetic Torque Ratchet 35NcmRA20352025-12-18
07290116777726OnePiece Pro Surgical Torque Ratchet 80NcmRA20802025-12-18
07290116777733OnePiece Elite Surgical Torque Ratchet 200Ncm RA22002025-12-18
07290116777740Star Hand Driver - Extra Long RP00092025-12-18
07290116777757Star Handpiece Driver - Extra Long RP00292025-12-18
07290116777764Star Torque Driver - Extra Long RP00362025-12-18
07290116777771Angulated Star Screw Hand Driver - Extra Long RP64082025-12-18
07290116777788Angulated Star Screw Torque Driver - Extra Long RP64092025-12-18
072901167778181.27 Hex Torque Driver - Extra Long RS60842025-12-18
072901167778251.27 Hex Driver for Handpiece - Extra Long RS90372025-12-18
07290116778327TorqLine™ 1.27 Hex Driver - ShortPT10102025-12-18
07290116778334TorqLine™ 1.27 Hex Driver - MediumPT10182025-12-18
07290116778341TorqLine™ 1.27 Hex Driver - LongPT10262025-12-18
07290116778358TorqLine™ Star Driver - ShortPT30102025-12-18

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