FDA.reportPublic FDA data

DS Implants

Primary DI
07392532186424
Brand
DS Implants
Company
Dentsply Implants Manufacturing GmbH
Model
26205
Catalog number
26205
Device description
SmartFix® Guide
Published
2022-07-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
07392532186424PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07392532186424073925321864247392532186424

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide, reusableA manual surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone); some types are also intended for guiding bone-coring instruments (e.g., keel punch). It is designed in a tubular form or with guiding holes and may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle or be held by another device (e.g., orthopaedic jig), and typically allows protection of the surrounding soft tissue during surgery. It is typically made of metal and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device.

Regulatory Flags#

DUNS number
344038836
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07392532219481ANKYLOS® Ratchet insert for extraction bolt31034693310346932022-07-14
07392532290282Astra Tech Implant System EV Surgical Tray GS680172012026-09-29
07392532290299Astra Tech Implant System EV Surgical Tray680152772026-09-29
D716IOSCRM30400SYMBIOS®USOSCRM3040OSCRM30402017-06-24
D716OSCRM15200SYMBIOS®USOSCRM1520OSCRM15202017-06-24
D716OSCRM20300SYMBIOS®USOSCRM2030OSCRM20302017-06-24
D716OSNRM12240SYMBIOS®USOSNRM1224OSNRM12242017-06-24
D716OSNRM25300SYMBIOS®USOSNRM2530OSNRM25302017-06-24
D716OSTRNRM12200SYMBIOS®USOSTRNRM1220OSTRNRM12202017-06-24
D716OSTRNRM25300SYMBIOS®USOSTRNRM2530OSTRNRM25302017-06-24
EFRI9000001041SYMBIOS®9000001049000001042017-06-30
EFRI9000003041SYMBIOS®9000003049000003042017-06-30
EFRI9200001041SYMBIOS®9200001049200001042017-06-30
EFRI9300001041SYMBIOS®9300001049300001042017-06-30
EFRI9300003041SYMBIOS®9300003049300003042017-06-30
EFRI9400000541SYMBIOS®9400000549400000542017-06-30
EFRI9400001041SYMBIOS®9400001049400001042017-06-30
EFRI9400003041SYMBIOS®9400003049400003042017-06-30
EFRI9700001041SYMBIOS®9700001049700001042017-06-30
EFRI9700003041SYMBIOS®9700003049700003042017-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640149886726TRITRI Dental Implants Int. AGNDP2026-10-06
07640149886733TRITRI Dental Implants Int. AGNDP2026-10-06
07640149886757TRITRI Dental Implants Int. AGNDP2026-10-06
07640149886764TRITRI Dental Implants Int. AGNDP2026-10-06
06009544030287N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052401N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052418N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052425N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052432N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052517N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052524N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052531N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052548N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052555N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052630N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052647N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052654N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052661N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052678N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052685N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052692N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052708N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052715N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052722N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052739N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052746N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052753N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052760N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052777N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544053224N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01