FDA.reportPublic FDA data

ACE

Primary DI
00614950021116
Brand
ACE
Company
ACE SURGICAL SUPPLY CO., INC.
Model
20971001
Catalog number
20971001
Device description
DEPTH GAUGE F/3.75 ST IMPLANTS (TI6AL4VELI)
Published
2019-10-19
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
EILGAUGE, DEPTH, INSTRUMENT, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EILGauge, Depth, Instrument, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00614950021116PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00614950021116006149500211166149500211160614950021116

GMDN Terms#

Term, Definition table
TermDefinition
Dental implantation depth/angle gauge, reusableA device designed to be used during the planning and post-osteotomy stages of a dental implantation procedure, prior to surgical implant placement/fixation, to measure/determine various lengths (e.g., drill depth of the osteotomy cavity, mucosal height, distance between implants/teeth for determining the mesiodistal position of the implant) and/or angles [e.g., direction of the perforation in relation to the antagonist arch], typically to help select an appropriate final prosthetic abutment to be installed. It is typically graduated and may be a hand-held instrument or a stand-alone device placed intraorally; some types are intended for use during x-ray imaging. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00No special storage conditions required

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
042763706
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
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
G149TBSB1270TBS BASICSACME ENTERPRISE.EIL2026-05-20
G149TBSB4230TBS BASICSACME ENTERPRISE.EIL2026-05-20
G149TBSB4240TBS BASICSACME ENTERPRISE.EIL2026-05-20
G149TBSB4250TBS BASICSACME ENTERPRISE.EIL2026-05-20
G149TBSB4260TBS BASICSACME ENTERPRISE.EIL2026-05-20
J003SVN620451Thermafil Plus size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-04-17
J003SVN650901Thermafil Plus size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-04-17
J003VXSV620451Vortex Size VerifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-04-17
J0036692981Densfil size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J0036693001Densfil size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J0036693011Densfil size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J0036693021Densfil size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J0036693031Densfil size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J0036693041Densfil size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J0036693051Densfil size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J0036693061Densfil size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J0036693071Densfil size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J0036693081Densfil size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTGSVF11Protaper Gold Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTGSVF21Protaper Gold Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTGSVF31Protaper Gold Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTGSVF41Protaper Gold Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTGSVF51Protaper Gold Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTNSVAST1Protaper Next Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTNSVX21Protaper Next Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTNSVX31Protaper Next Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTNSVX41Protaper Next Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTNSVX51Protaper Next Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTUSVAST1Protaper Universal Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTUSVF11Protaper Universal Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26