FDA.reportPublic FDA data

ANKYLOS®

Primary DI
07392532219306
Brand
ANKYLOS®
Company
Dentsply Implants Manufacturing GmbH
Model
31034530
Catalog number
31034530
Device description
Elevator 03
Published
2022-11-10
Public version status
Update
Distribution status
Not 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
EMMCHISEL, OSTEOTOME, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMMChisel, Osteotome, SurgicalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07392532219306PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07392532219306073925322193067392532219306

GMDN Terms#

Term, Definition table
TermDefinition
Periosteal elevator, reusableA hand-held manual surgical instrument designed to lift/separate (elevate) or tunnel under the periosteum during surgery, typically orthopaedic, including use on the ribs. It may in addition be used in dentistry to access retained roots, or to remove them with surrounding bone. It is typically a one-piece instrument available in a variety of sizes and blade designs, including straight and curved blades, and often double-ended with a central handle; it is made of metal [e.g., stainless steel, titanium (Ti)]. 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
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
EFRIOSCRM15200SYMBIOS®USOSCRM1520OSCRM15202017-02-03
EFRIOSCRM20300SYMBIOS®USOSCRM2030OSCRM20302017-02-03
EFRIOSCRM30400SYMBIOS®USOSCRM3040OSCRM30402017-02-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G879OSTCVC220DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCVC270DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCVC320DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCVC370DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCVC420DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCVS220DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCVS270DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCVS320DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCVS370DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCVS420DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCXC220DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCXC270DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCXC320DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCXC370DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCXC420DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCXS220DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCXS270DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCXS320DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCXS370DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCXS420DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
04099797012989SCREW-LINE Osteotomy setALTATEC GmbHEMM2026-08-17
04099797012996SCREW-LINE Osteotomy setALTATEC GmbHEMM2026-08-17
04099797013016SCREW-LINE OsteotomeALTATEC GmbHEMM2026-08-17
04099797013047SCREW-LINE OsteotomeALTATEC GmbHEMM2026-08-17
04099797013078SCREW-LINE OsteotomeALTATEC GmbHEMM2026-08-17
04099797013108SCREW-LINE OsteotomeALTATEC GmbHEMM2026-08-17
04099797013139SCREW-LINE OsteotomeALTATEC GmbHEMM2026-08-17
04099797013153SCREW-LINE OsteotomeALTATEC GmbHEMM2026-08-17
04099797013184SCREW-LINE OsteotomeALTATEC GmbHEMM2026-08-17
04099797013214SCREW-LINE OsteotomeALTATEC GmbHEMM2026-08-17