FDA.report

American Dental Implant

Primary DI
D8964DRWEL0
Brand
American Dental Implant
Company
AMERICAN DENTAL IMPLANT CORPORATION
Model
4DRWEL
Catalog number
4DRWEL
Device description
Ratchet Extension Long (4mm Square Drive System)
Published
2018-07-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D8964DRWEL0PrimaryHIBCC0

GMDN Terms

TermDefinition
Surgical torque wrench adaptorA component of a surgical wrench (typically ratchet type) intended to enable connection of the main body of the wrench to a variety of distal end pieces (bits). It is intended to be used during an invasive surgical procedure, and is not dedicated to dental use only. It may be referred to as a driver. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
8005110661info@americandentalimplant.com

Regulatory Flags

DUNS number
835556429
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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D8963250115SD0American Dental Implant3250115SD3250115SD2024-04-10
D896325010SD0American Dental Implant325010SD325010SD2024-04-10
D896325013SD0American Dental Implant325013SD325013SD2024-04-10
D896325015SD0American Dental Implant325015SD325015SD2024-04-10
D896ADTD200American Dental Implant ADTD20ADTD202018-07-31
D896ADTD20S0American Dental Implant ADTD20SADTD20S2018-07-31
D896ADTD230American Dental Implant ADTD23ADTD232018-07-31
D896ADTD23S0American Dental Implant ADTD23SADTD23S2018-07-31
D896ADTD280American Dental Implant ADTD28ADTD282018-07-31
D896ADTD28S0American Dental Implant ADTD28SADTD28S2018-07-31
D896ADTD300American Dental Implant ADTD30ADTD302018-07-31
D896ADTD30S0American Dental Implant ADTD30SADTD30S2018-07-31
D896ADTD320American Dental Implant ADTD32ADTD322018-07-31
D896ADTD32S0American Dental Implant ADTD32SADTD32S2018-07-31
D896ADTD32T0American Dental Implant ADTD32TADTD32T2018-07-31
D896ADTD340American Dental Implant ADTD34ADTD342018-07-31
D896ADTD34S0American Dental Implant ADTD34SADTD34S2018-07-31
D896ADTD380American Dental Implant ADTD38ADTD382018-07-31
D896ADTD38S0American Dental Implant ADTD38SADTD38S2018-07-31
D896ADTD440American Dental Implant ADTD44ADTD442018-07-31

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