FDA.report

Drill S-5.5, 3.2/2.5mmDx11.5mmL

Primary DI
07290109300047
Brand
Drill S-5.5, 3.2/2.5mmDx11.5mmL
Company
ADIN DENTAL IMPLANT SYSTEMS LTD
Model
GS1132
Published
2020-11-25
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
07290109300047PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07290109300047072901093000477290109300047

GMDN Terms

TermDefinition
Fluted surgical drill bit, reusableA shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is usually inserted into a surgical power tool or a surgical hand drill/brace. 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

Primary DIBrandModelCatalogPublished
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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
D7717248LTF1Dental CityICP, INC.EJL2026-05-26
D7717270021Dental CityICP, INC.EJL2026-05-26
D7717270031Dental CityICP, INC.EJL2026-05-26
D7717270041Dental CityICP, INC.EJL2026-05-26
D7717270061Dental CityICP, INC.EJL2026-05-26
D7717270081Dental CityICP, INC.EJL2026-05-26
D7717270091Dental CityICP, INC.EJL2026-05-26
D7717271041Dental CityICP, INC.EJL2026-05-26
D7717271061Dental CityICP, INC.EJL2026-05-26
D7717271081Dental CityICP, INC.EJL2026-05-26
D7717271141Dental CityICP, INC.EJL2026-05-26
D7717272041Dental CityICP, INC.EJL2026-05-26
D7717272051Dental CityICP, INC.EJL2026-05-26
D7717272061Dental CityICP, INC.EJL2026-05-26
D7717272141Dental CityICP, INC.EJL2026-05-26
D7717272741Dental CityICP, INC.EJL2026-05-26
D7717273031Dental CityICP, INC.EJL2026-05-26
D7717273041Dental CityICP, INC.EJL2026-05-26
D7717273771Dental CityICP, INC.EJL2026-05-26
D7717273781Dental CityICP, INC.EJL2026-05-26
D7717273791Dental CityICP, INC.EJL2026-05-26
D7717274041Dental CityICP, INC.EJL2026-05-26
D7717274061Dental CityICP, INC.EJL2026-05-26
D7717274081Dental CityICP, INC.EJL2026-05-26
D7717275721Dental CityICP, INC.EJL2026-05-26
D7717275831Dental CityICP, INC.EJL2026-05-26
D7717276131Dental CityICP, INC.EJL2026-05-26
D7717276421Dental CityICP, INC.EJL2026-05-26
D7717276641Dental CityICP, INC.EJL2026-05-26
D7717276761Dental CityICP, INC.EJL2026-05-26