FDA.reportPublic FDA data

TRI-CAM Dental Implant System

Primary DI
00614950028238
Brand
TRI-CAM Dental Implant System
Company
ACE SURGICAL SUPPLY CO., INC.
Model
30952702
Catalog number
30952702
Device description
TRI-CAM Drill 3.5mm x 10 TL 4 Flutes Tapered
Published
2023-06-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZADRILL, DENTAL, INTRAORAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZADrill, Dental, IntraoralDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00614950028238PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00614950028238006149500282386149500282380614950028238

GMDN Terms#

Term, Definition table
TermDefinition
Fluted surgical drill bit, reusableA shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is usually inserted into a surgical power tool or a surgical hand drill/brace. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length10Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)588-3100regulatoryandquality@acesurgical.com

Regulatory Flags#

DUNS number
042763706
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00614950025510ACE003293700329372019-10-24
00614950025558ACE080000208000022019-10-24
00614950025565ACE080000308000032019-10-24
00614950025572ACE080001108000112019-10-24
00614950013425ACE003105900310592019-10-16
00614950031207ACE484200248420022023-12-05
00614950031214ACE484200348420032023-12-05
00614950030149ACE20982511209825112023-12-05
00614950030927ACE45450201454502012023-12-05
00614950012831ACE90440018S90440018S2019-10-13
00614950012848ACE90440018ST90440018ST2019-10-13
00614950026272ACE90250018902500182019-10-13
00614950026289ACE90250023902500232019-10-13
00614950026296ACE90440018904400182019-10-13
00614950026302ACE90440023904400232019-10-13
00614950026319ACE90440023S90440023S2019-10-13
00614950026326ACE90440023ST90440023ST2019-10-13
00614950026333ACE90500018905000182019-10-13
00614950026340ACE90500018S90500018S2019-10-13
00614950026357ACE90500023905000232019-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00887919581727DENTFLEX FIBER POSTPeter Brasseler Holdings, LLCDZA2026-09-25
00887919581741DENTFLEX FIBER POSTPeter Brasseler Holdings, LLCDZA2026-09-25
00887919581765DENTFLEX FIBER POSTPeter Brasseler Holdings, LLCDZA2026-09-25
08800394921293Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921309Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921316Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921323Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921330Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921347Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921354Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921361Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921378Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921385Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921392Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921408Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921415Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921422Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921439Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921446Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921453Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921460Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921477Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
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08059224218014INVASIVE ACCESSORIES AND INSTRUMENTSRHEIN 83 SRLDZA2026-08-27
08059224218038INVASIVE ACCESSORIES AND INSTRUMENTSRHEIN 83 SRLDZA2026-08-27
08059224218250INVASIVE ACCESSORIES AND INSTRUMENTSRHEIN 83 SRLDZA2026-08-27
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06942686761254DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21