FDA.reportPublic FDA data

EZ Stopper

Primary DI
00814639022391
Brand
EZ Stopper
Company
APPLIED DENTAL, INC.
Model
D017-STPS
Catalog number
D017-STPS
Device description
Dental Implant Depth Control Stopper Set
Published
2022-03-15
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814639022391PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814639022391008146390223918146390223910814639022391

GMDN Terms#

Term, Definition table
TermDefinition
Dental implantation depth/angle gauge, reusableA device designed to be used during the planning and post-osteotomy stages of a dental implantation procedure, prior to surgical implant placement/fixation, to measure/determine various lengths (e.g., drill depth of the osteotomy cavity, mucosal height, distance between implants/teeth for determining the mesiodistal position of the implant) and/or angles [e.g., direction of the perforation in relation to the antagonist arch], typically to help select an appropriate final prosthetic abutment to be installed. It is typically graduated and may be a hand-held instrument or a stand-alone device placed intraorally; some types are intended for use during x-ray imaging. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
888-841-8481info.usa@ad-surgical.com

Regulatory Flags#

DUNS number
017524666
Device count
1
DM exempt
true
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
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10814639026747Premium UNIFY Silk SuturesPMS-318R192025-06-20
10814639026754Premium UNIFY Silk SuturesPMS-418R192025-06-20
10814639026761Premium UNIFY Silk SuturesPMS-518R192025-06-20
10814639026778Premium UNIFY Silk SuturesPSS-418R132025-06-20
10814639026785Premium UNIFY Silk SuturesPSS-518R132025-06-20
10814639026792Premium UNIFY Silk SuturesPSS-618R132025-06-20
10814639026563UNIFY Chromic Gut Surgical SuturesM-C318R192025-06-19
10814639026587UNIFY Chromic Gut Surgical SuturesM-C418R162025-06-19
10814639026594UNIFY Chromic Gut Surgical SuturesM-C518R162025-06-19
10814639026600UNIFY Chromic Gut Surgical SuturesS-C618R132025-06-19
10814639026617UNIFY Plain Gut SuturesS-J618R132025-06-19
10814639026624UNIFY Plain Gut Surgical SuturesL-J230R24L-J230R242025-06-19
10814639026648UNIFY Plain Gut SuturesM-J318R192025-06-19
10814639026655UNIFY Plain Gut SuturesM-J418R162025-06-19
10814639026662UNIFY Plain Gut SuturesM-J430R19M-J430R192025-06-19
10814639026679UNIFY Plain Gut SuturesM-J518R162025-06-19
10814639026686UNIFY Chromic Surgical Sutures M-C518R19 2025-06-19
10814639026693UNIFY Plain Gut SuturesM-J518R192025-06-19
10814639026730UNIFY Polyester Surgical SuturesL-E230R262025-06-19
10814639026808UNIFY Polyester Surgical SuturesS-E418R132025-06-19

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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