510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Groman Inc.

Coconut Creek, FL, US

GROMAN INC. appears in FDA device records in Coconut Creek, FL. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 1 510(k) clearance for Groman Inc. in 2003.

Clearances by year, as a table
510(k) clearance decisions for Groman Inc., by decision year
YearClearances
20031
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K030292GROMAN PREPMASTERKOJSubstantially Equivalent

Registered establishments

FDA registered establishments for Groman Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30043614443004361444GROMAN INC.2000 Banks Rd Ste G1, Coconut Creek, FL 33063 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0742-2012New Label: EtchMaster ***Cordless Handpiece***P/N 797 www.GromanDental.com 1800-906-9298 HAZARD WARNING: Using CO2 cartridges from other suppliers may cause an operational hazard and will void the warrantee. Old Label: EtchMaster***Cordless Handpiece***Pats. Pend. Groman, Inc. Adapater P/N 747 WWW.DisposableAirAbrasion.com 1-800-906-9298. The Cordless Etcher air brush is powered by CO2 mini-cartridges to deliver pressurized gas to the EtchMaster pre-filled disposable micro air abrasive tips. The Cordless Etcher handpiece is quickly re-loaded with a CO2 mini-cartridge. Each CO2 mini-cartridge provides sufficient power to run 3 EtchMaster tips. The EtchMaster tips are used to abrade tooth surfaces and prosthetic devices prior to bonding procedures.Groman Inc. of Margate, FL recalled their product Cordless Etcher Air Brush. When non-conforming cartridges are inserted into the Cordless Etcher they can induce excessive stresses on the device causing cracks in the plastic housing of the device. These crack can lead to a hazardous situation due to the high pressure of the gas contained in the CO2 cartridges.Terminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain