FDA.reportPublic FDA data

SPATULA

Primary DI
00888118004246
Brand
SPATULA
Company
KLS-Martin L.P.
Model
01-020-01-07
Published
2018-09-26
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
00888118004246PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118004246008881180042468881180042460888118004246

GMDN Terms#

Term, Definition table
TermDefinition
Dental osteotomeA hand-held, dental, surgical instrument used during dental osteotomy for shaping and condensing bone, typically when performing a dental implant surgical procedure. It is hand-held by the dentist who will use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument. The device will have a straight or bayonet-shaped handle leading to a round or concave tip at the distal end, which may be marked with graduations to indicate depth differences. It is used for ridge expanding, bone condensing and sinus floor elevation procedures. This device will be made of high-grade stainless steel. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(904)641-7746KLS-UDI-Info@klsmartin.com

Regulatory Flags#

DUNS number
826499238
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888118145819IPS60-011-13-09-LP2026-10-01
00888118145826IPS60-011-14-09-LP2026-10-01
00888118145833IPS60-011-15-09-LP2026-10-01
00888118145840IPS60-011-16-09-LP2026-10-01
00888118145857IPS60-011-17-09-LP2026-10-01
00888118145864IPS60-011-18-09-LP2026-10-01
00888118036261LEVEL ONE CMF25-038-30-092016-03-24
00888118036278LEVEL ONE CMF25-038-35-092016-03-24
00888118036285LEVEL ONE NEURO25-040-25-092016-03-24
00888118036292LEVEL ONE NEURO, STERILE25-040-25-712016-03-23
00888118036339LEVEL ONE CMF25-040-35-092016-03-24
00888118036346LEVEL ONE CMF25-040-40-092016-03-24
00888118036360LEVEL ONE NEURO25-042-02-092016-03-24
00888118036391LEVEL ONE NEURO25-042-05-092016-03-24
00888118036483LEVEL ONE CMF, STERILE25-042-20-712016-03-23
00888118092618LEVEL ONE CMF25-043-06-092016-03-24
00888118155498IPS60-500-15-092026-09-28
00888118155504IPS60-500-15-09-LP2026-09-28
00888118155511IPS60-500-15-09-PP2026-09-28
00888118155528IPS60-500-17-092026-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776432836MillenniumAvalign Technologies, Inc.EMM2026-09-29
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