FDA.report

Handpiece Socket L10.5

Primary DI
07290109301037
Brand
Handpiece Socket L10.5
Company
ADIN DENTAL IMPLANT SYSTEMS LTD
Model
GS0021
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
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07290109301037PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07290109301037072901093010377290109301037

GMDN Terms

TermDefinition
Dental power tool converter attachment, non-rotaryA dental attachment, commonly known as a ratchet adaptor, drive converter, or dental turbine, designed to be fitted in a dental power tool handpiece to convert energy (e.g., electrical, pneumatic) to a sagittal, oscillating or reciprocating mechanical motion to achieve a specific function (e.g., sawing) during dental procedures [e.g., maxillofacial surgery]. It is not an endpiece; an appropriate interchangeable endpiece (e.g., saw blade) is intended to be fixed to the working end of this device. 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

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07290116777658OnePiece Wrench RatchetRA10002025-12-18
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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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