FDA.report

ACE

Primary DI
00614950010707
Brand
ACE
Company
ACE SURGICAL SUPPLY CO., INC.
Model
0300001
Catalog number
0300001
Device description
ELEVATOR PERIOSTEAL SELDIN #23 7-3/4" 19.5CM
Published
2019-10-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
EMJELEVATOR, SURGICAL, DENTAL

Product Code Classifications

CodeDeviceSpecialtyClass
EMJElevator, Surgical, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00614950010707PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00614950010707006149500107076149500107070614950010707

GMDN Terms

TermDefinition
Dental root elevatorA hand-held manual dental instrument intended to be used as a lever during the extraction of a tooth or retained roots. It is typically a one-piece instrument with a strong but slender blade at the distal working end, or it may be double-ended with a central handle. It is available in a variety of sizes and blade designs and is pushed in between the gums and the tooth exterior to loosen the tissue surrounding the tooth. Sometimes this can be enough to loosen and extract the tooth without the use of other instruments. This is a reusable device.

Device Sizes

TypeValueUnit
Length19.5Centimeter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00No special storage conditions required

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)441-3100ritaknight@acesurgical.com

Regulatory Flags

DUNS number
042763706
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00614950031863BioPlugBH0054BH00542024-05-22
00614950031870BioStripBH00055BH000552024-05-22
00614950029525ACE400000140000012023-12-05
00614950029532ACE401500240150022023-12-05
00614950029549ACE400200740020072023-12-05
00614950029556ACE603901560390152023-12-05
00614950029563ACE603901660390162023-12-05
00614950029570ACE442305044230502023-12-05
00614950029587ACE090010209001022023-12-05
00614950029594Macan003333900333392023-12-05
00614950029600Macan526003552600352023-12-05
00614950029617Macan526003852600382023-12-05
00614950029624Macan526600052660002023-12-05
00614950029631Macan003334200333422023-12-05
00614950029648Macan526004552600452023-12-05
00614950029655Macan003333700333372023-12-05
00614950029662Macan526002652600262023-12-05
00614950029679ACE400520340052032023-12-05
00614950029686Macan003337600333762023-12-05
00614950029693Macan526002952600292023-12-05

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00348783004069Premier ElevatorPREMIER DENTAL PRODUCTS COMPANYEMJ2026-03-17
00348783004076Premier ElevatorPREMIER DENTAL PRODUCTS COMPANYEMJ2026-03-17
00348783004182Premier ElevatorPREMIER DENTAL PRODUCTS COMPANYEMJ2026-03-17
00348783004229Premier ElevatorPREMIER DENTAL PRODUCTS COMPANYEMJ2026-03-17
00192896122772Winged ElevatorSONTEC INSTRUMENTS, INC.EMJ2026-03-10
00192896122789Winged ElevatorSONTEC INSTRUMENTS, INC.EMJ2026-03-10
G1493803201TBS DentalACME ENTERPRISE.EMJ2026-03-03
G1493803302TBS DentalACME ENTERPRISE.EMJ2026-03-03
G1493801502TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493801704TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493801805TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493801906TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493802200TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493802301TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493802402TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493802503TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493802604TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493803100TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493803403TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493803504TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493803605TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493807104TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493809106TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493850102TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493850203TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493850304TBS DentalACME ENTERPRISE.EMJ2026-03-02
G149TBSRPKIT00TBS DentalACME ENTERPRISE.EMJ2026-03-02
00840018672369Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMJ2026-02-11
00840018667556Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMJ2026-02-10
00840018666535Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMJ2026-02-09