FDA.reportPublic FDA data

DP285-1

Primary DI
07640166769675
Brand
DP285-1
Company
Z-Systems AG
Model
DP285-1
Catalog number
DP285-1
Device description
Depth Probe 2.85 mm
Published
2026-05-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
07640166769675PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640166769675076401667696757640166769675

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+41623886969support@zsystems.com

Regulatory Flags#

DUNS number
483189556
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
07640166763567Z5m(t)-neoZ5m(t)-neo-4008Z5m(t)-neo-40082026-05-17
07640166763574Z5m(t)-neoZ5m(t)-neo-4010Z5m(t)-neo-40102026-05-17
07640166763581Z5m(t)-neoZ5m(t)-neo-4012Z5m(t)-neo-40122026-05-17
07640166763703Z5m(t)-neoZ5m(t)-neo-5008Z5m(t)-neo-50082026-05-17
07640166763710Z5m(t)-neoZ5m(t)-neo-5010Z5m(t)-neo-50102026-05-17
07640166763727Z5m(t)-neoZ5m(t)-neo-5012Z5m(t)-neo-50122026-05-17
07640166763741FD400-neoFD400-neoFD400-neo2026-05-17
07640166763758FD500-neoFD500-neoFD500-neo2026-05-17
07640166765905TD230-1TD230-1TD230-12026-05-17
07640166765936TD285-1TD285-1TD285-12026-05-17
07640166769521Z5m(t)-neo InsertZ5m(t)-neo InsertZ5m(t)-neo Insert2026-05-17
07640166769651Z5m(t)-neo Tray FullZ5m(t)-neo Tray FullZ5m(t)-neo Tray Full2026-05-17
07640166769668DP230-1DP230-1DP230-12026-05-17
07640166760405Z5cZ5c-40-08Z5c-40-082015-08-25
07640166760412Z5cZ5c-40-10Z5c-40-102015-08-25
07640166760429Z5cZ5c-40-12Z5c-40-122015-08-25
07640166760436Z5cZ5c-50-08Z5c-50-082015-08-25
07640166760443Z5cZ5c-50-10Z5c-50-102015-08-25
07640166760450Z5cZ5c-50-12Z5c-50-122015-08-25
07640166769491Z5mZ5m-36-10Z5m-36-102015-08-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
EMKA013529MEDENTiKAMEDENTiKA GmbHNDP2020-04-30
EMKA005039MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013049MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013059MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013189MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013229MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013239MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013289MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013369MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013379MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013389MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013399MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013509MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013599MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013609MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013619MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013769MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013829MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA019019MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA021019MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA021029MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA023019MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA023029MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA028129MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA028139MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA028209MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA028219MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA031019MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA031049MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA031059MEDENTiKAMEDENTiKA GmbHNDP2020-04-08