FDA.reportPublic FDA data

EXCAVATOR SPOON

Primary DI
00192896050266
Brand
EXCAVATOR SPOON
Company
SONTEC INSTRUMENTS, INC.
Model
1102-REEC1
Catalog number
1102-REEC1
Device description
EXCAVATOR SPOON #1 DOUBLE ENDED TIPS LIGHT HANDLE
Published
2018-10-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EKCExcavator, Dental, Operative

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKCExcavator, Dental, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896050266PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896050266001928960502661928960502660192896050266

GMDN Terms#

Term, Definition table
TermDefinition
Dental excavator, reusableA hand-held manual dental instrument designed for cutting, scraping, and removing the carious dentine of a decayed tooth or other pathological bone tissue within the oral cavity. It is made of high-grade stainless steel typically designed as a double-ended instrument, having a central handle, with small, sharp, spoon-, scoop-, or spatula-shaped blades that have sharp cutting/gouging edges. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter1.2Millimeter

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""Dry Heat Sterilization""]"
Moist Heat or Steam Sterilization;Dry Heat Sterilization

Contacts#

Phone, Email table
PhoneEmail
800-821-7496info@sontecinstruments.com

Regulatory Flags#

DUNS number
040729840
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
00192896123793Adson Tissue Forceps140-302DLQ140-302DLQ2026-10-06
00192896123809Micro Skinner Forceps140-519M140-519M2026-10-06
00192896123816Jacobson Needle Holder2300-142D2300-142D2026-10-06
00192896123823Thumb Dressing Forceps136-610Q136-610Q2026-10-06
00192896123830Thumb Dressing Forceps136-615Q136-615Q2026-10-06
00192896123847Thumb Dressing Forceps136-619Q136-619Q2026-10-06
00192896123854Gum Scissors475-153Q475-153Q2026-10-06
00192896111394Laparoscopic Bulldog Clamp2901-281-60T2901-281-60T2021-10-22
00192896056282ALLIGATOR FORCEPS1271-0101271-0102018-09-27
00192896123755Debakey-Diethrich Tissue Forceps442-239P442-239P2026-09-18
00192896123762TAVR Removal Set2400-200-SET2400-200-SET2026-09-18
00192896123779Waever Chalazion Forceps14-988014-98802026-09-18
00192896123786Prince Trachoma Eye Forceps14-968014-96802026-09-18
00192896123632Adson Dressing Forceps140-299S140-299S2026-08-27
00192896123649Converse Scissors460-156L460-156L2026-08-27
00192896123656Ferguson Abdominal Scissors110-287110-2872026-08-27
00192896123663Meyerding Finger Retractor205-856Q205-856Q2026-08-27
00192896123670Meyerding Finger Retractor205-857Q205-857Q2026-08-27
00192896122499Cartilage Graft Cutter350-842350-8422025-11-21
00192896122048Ceramitec Universal Klick Ferris Smith Rongeur Shaft404-312B404-312B2026-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G8791022620DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-17
G8791022630DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-17
G8791022640DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-17
G8791022950DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-17
G8791022960DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-17
G8791022970DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-17
G8791022980DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-17
G8791027580DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-17
G8791027590DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-17
G8791027600DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-17
G87910217W0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-08
G87910218W0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-08
G87910219W0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-08
G8791022430DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-08
G8791022440DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-08
G8791022450DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-08
G8791022650DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-08
G8791022660DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-08
G8791022670DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-08
G879ENX11L0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-08
G879ENX31L0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-08
G879ENX31W0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-08
G879ENX32L0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-08
G879ENX33L0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-08
00850083275624Intrace USAPILOTIS TECH LLCEKC2026-07-03
00348783008500Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-06-08
00348783008517Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-06-08
00348783008524Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-06-08
00348783008531Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-06-08
00348783008548Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-06-08