FDA.reportPublic FDA data

EZ Stent

Primary DI
00814639020014
Brand
EZ Stent
Company
APPLIED DENTAL, INC.
Model
D015-004-P
Catalog number
D015-004-P
Device description
Dental Implant Guide - Free-end 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
Single use
true

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
10814639020011PackageGS1200In Commercial Distribution
00814639020014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081463902001110814639020011
00814639020014008146390200148146390200140814639020014

GMDN Terms#

Term, Definition table
TermDefinition
Dental guided surgery reference plateA non-sterile device in the form of a plate designed for the fabrication of custom-made scan and surgical dental implant templates used by a dentist during the first stage of a guided dental implantation procedure (i.e., drilling holes in the jawbone for implant placement/fixation). It is a plastic plate of a predefined shape and hole configuration for placement of dental guided surgery reference pins to form a link between a chairside cone beam computerized tomography (CBCT) scan and a coordinate system for dental laboratory fabrication of the scan template (used to scan the patient) and then the surgical dental implant template. This is a single-use device.

Storage And Handling#

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

Sterilization Methods#

Method table
Method
Hydrogen Peroxide

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
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814639026832UNIFY MicroSutures SilkXXS-S618S6DXXS-S618S6D2026-04-27
00814639026849UNIFY MicroSutures SilkXS-S618R11DXS-S618R11D2026-04-27
00814639021615UNIFY PGA Surgical SuturesXS-G618R11-U2015-08-21
00814639021622UNIFY PGA Surgical SuturesXS-G718R112015-08-21
00814639021660UNIFY Nylon Surgical SuturesXXS-N1012S6D2015-08-21
00814639021677UNIFY Nylon Surgical SuturesXXS-N807T62015-08-21
00814639021950Premium UNIFY PP SuturesPSP-518R132015-08-21
00814639021967Premium UNIFY Polypropylene SuturesPSP-618R132015-08-21
00814639022414Premium UNIFY PP SuturesPMP-518R192016-11-09
00814639022421Premium UNIFY PP SuturesPMP-418R192016-11-09
00814639022438Premium UNIFY PP SuturesPSP-418R132016-11-09
00814639022803Premium UNIFY PP SuturesPMP-418R162016-11-09
00814639023602UNIFY Nylon Surgical SuturesXXS-N1007S62017-08-02
00814639023732Premium UNIFY PP SuturesPLP-427R242020-08-03
00814639023749Premium UNIFY PP SuturesPLP-327R242020-08-03
00814639024135UNIFY Nylon Surgical SuturesXXS-N905T52020-07-30
00814639024142UNIFY Nylon Surgical SuturesXXS-N1005T42020-07-30
00814639024791Premium UNIFY PP SuturesPMP-318R192020-08-03
00814639025538UNIFY PGCL Surgical SuturesXS-Q518R112021-04-23
00814639025545UNIFY PGCL Surgical SuturesXS-Q518R11-C2021-04-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842092187722PreatPreat CorporationNDP2026-06-08
08056591028154JDentalCare Dental InstrumentsJ DENTAL CARE SRLNDP2026-06-08
00840481133756LOCATORZest Anchors, LLCNDP2026-06-05
07630031778086NAInstitut Straumann AGNDP2026-06-03
07630031778093NAInstitut Straumann AGNDP2026-06-03
07630031778109NAInstitut Straumann AGNDP2026-06-03
07630031778116NAInstitut Straumann AGNDP2026-06-03
07630031778123NAInstitut Straumann AGNDP2026-06-03
07630031778130NAInstitut Straumann AGNDP2026-06-03
07630031778147NAInstitut Straumann AGNDP2026-06-03
07630031778154NAInstitut Straumann AGNDP2026-06-03
07630031778161NAInstitut Straumann AGNDP2026-06-03
07630031778192NAInstitut Straumann AGNDP2026-06-03
07630031778208NAInstitut Straumann AGNDP2026-06-03
07630031778215NAInstitut Straumann AGNDP2026-06-03
07630031778222NAInstitut Straumann AGNDP2026-06-03
07630031778239NAInstitut Straumann AGNDP2026-06-03
07630031778260NAInstitut Straumann AGNDP2026-06-03
07630031778277NAInstitut Straumann AGNDP2026-06-03
07630031778284NAInstitut Straumann AGNDP2026-06-03
07630031778291NAInstitut Straumann AGNDP2026-06-03
07630031778307NAInstitut Straumann AGNDP2026-06-03
07630031778338NAInstitut Straumann AGNDP2026-06-03
07630031778345NAInstitut Straumann AGNDP2026-06-03
07630031778352NAInstitut Straumann AGNDP2026-06-03
07630031778369NAInstitut Straumann AGNDP2026-06-03
07630031778376NAInstitut Straumann AGNDP2026-06-03
07630031778406NAInstitut Straumann AGNDP2026-06-03
07630031778413NAInstitut Straumann AGNDP2026-06-03
07630031778420NAInstitut Straumann AGNDP2026-06-03