FDA.reportPublic FDA data

American Dental Implant

Primary DI
D896ADTD30S0
Brand
American Dental Implant
Company
AMERICAN DENTAL IMPLANT CORPORATION
Model
ADTD30S
Catalog number
ADTD30S
Device description
3.0mm Diameter Externally Irrigated Twist Pilot Drill Short (28mm Length)
Published
2018-07-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K945706000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K945706000BONE DRILLOsteo Implant Corp.1995-07-14DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D896ADTD30S0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Storage: Store In An Approved Sterilization Pouch

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
800-511-0661info@americandentalimplant.com

Regulatory Flags#

DUNS number
835556429
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D8963250115SD0American Dental Implant3250115SD3250115SD2024-04-10
D896325010SD0American Dental Implant325010SD325010SD2024-04-10
D896325013SD0American Dental Implant325013SD325013SD2024-04-10
D896325015SD0American Dental Implant325015SD325015SD2024-04-10
D8964DTW200American Dental Implant4DTW204DTW202018-07-31
D8964DTW300American Dental Implant4DTW304DTW302018-07-31
D8963ASAB0American Dental Implant3AS-AB3AS-AB2019-02-18
D8963ASB0American Dental Implant3AS-B3AS-B2019-02-18
D8963AS0American Dental Implant3AS3AS2018-07-31
D896AS0American Dental ImplantASAS2018-07-31
D896ASA0American Dental ImplantAS-AAS-A2018-07-31
D896ASAG0American Dental ImplantAS-AGAS-AG2018-07-31
D896ASAP0American Dental ImplantAS-APAS-AP2018-07-31
D896ASG0American Dental ImplantAS-GAS-G2018-07-31
D896ASP0American Dental ImplantAS-PAS-P2018-07-31
D896ASY0American Dental ImplantAS-YAS-Y2018-07-31
D896ADTD200American Dental Implant ADTD20ADTD202018-07-31
D896ADTD20S0American Dental Implant ADTD20SADTD20S2018-07-31
D896ADTD230American Dental Implant ADTD23ADTD232018-07-31
D896ADTD23S0American Dental Implant ADTD23SADTD23S2018-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08806395200535Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200542Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200559Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200566Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200573Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200580Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200597Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200603Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200610Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200627Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200634Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200641Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200658Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200665Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200672Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200689Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200696Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200702Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200719Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200726Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200733Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200740Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200757Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200764Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200771Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200788Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200795Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200801Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200818Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200825Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28